510 (K) Summary: C0Ozt

KD-5l2 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA5IO(k) Files
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirement of SMDA and 21 CFR
807.92.
1.0 submitter's information NOV"' ;' 3 201Th.
Name: Andon Health Co., Ltd.

Address: No 3, Jinping Street Ya An Road, Nankai District,
Tianjin, P.R. China
Phone number: 86-22-6052 6161
Fax number: 86-22-6052 6162
Contact: Liu Yi
Date of Application: 09/27/20 10
2.0 Device information
Trade name: Fully Automatic Electronic Blood Pressure Monitor

Common name: Noninvasive blood pressure measurement system
Classification name: Noninvasive blood pressure measurement system
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system.

Regulation number: 870.1130
Classification: II
Panel: Cardiovascular
4.0 Predicate device information
Manufacturer: Andon Health Co., Ltd.
Device: KD-556 Fully Automatic Electronic Blood Pressure

1 Monitor
510(k) number: K090963
Manufacturer: Andon Health Co., Ltd.
2Device: KD-738 Fully Automatic Electronic Blood Pressure

Monitor
__510(k) number: K092045
5- I
KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
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5.0 Device description
KD-512 Fully Automatic Electronic Blood Pressure Monitor are for use by
medical professionals or at home and is a non-invasive blood pressure
measurement system intended to measure the diastolic and systolic blood
pressures and pulse rate of an adult individual by using a non-invasive
technique in which an inflatable cuff is wrapped around the upper arm. The
cuff circumference is limited to 22cm-48cm.
KD-712 Fully Automatic Electronic Blood Pressure Monitor is for use by

technique in which an inflatable cuff is wrapped around the wrist. The cuff
circumference is limited to l4cm-25cm.
It is designed and manufactured according to ANSI/AAMI SP1O--manual,

electronic or automated sphygmanomneters.
The operational principle is based on oscillomnetric and silicon integrate

pressure sensor technology. It can calculate the systolic and diastolic blood
pressure, and display the result on the LCD. If any irregular heartbeat is
detected, it can also be shown on the LCD. More over, it also calculates the
average of the last three measurements.
6.0 Intended use

The intended use and the indication for use of KD-512, as described in the
5- 2
KD-5l2 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA5iO(k) Files
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labeling are the same as their predicated device KD-556. While the
intended use and the indication for use of KD-712 is the same as its
predicated devices KID-735.
7.0 Summary comparing technological characteristics with predicate

device
Technological Characteristics Comparison result

Design principle Identical
Appearance Similar
Patients contact Materials Identical
Performance Similar
Biocompatibility Identical
Mechanical safety Identical
Energy source Identical
Standards met Identical
Electrical safety Identical
EMVC Identical
Function Similar
5- 3
KD-5 12 and KD-7 12 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
8.0 Performance summaryI'
KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor

conforms to the following standards:
* lEG 60601-1, Medical Electrical Equipment - Part 1: General
Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2,
1995.
* EN 60601-1-2, Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral standard: Electromagnetic
Compatibility - Requirements and Tests, 2007.
* AAMI SP1O0:2002, Manual, electronic or automated sphygmomanometers.
* AAMI I ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSIIAAMI
SP1O0:2002 Manual, electronic, or automated sphygmomanometers.
* AAMI I ANSI SP10:2002/A2:2006 -- , Amendment 2 to ANSIIAAMI
SP1O:2002 Manual, electronic, or automated sphygmomanometers.
9.0 Comparison to the predicate device and the conclusion
Our device KD-512 Fully Automatic Electronic Blood Pressure Monitor is

substantially equivalent to. the Fully Automatic Electronic Blood Pressure
Monitor KD-556 whose 510(k) number is K090963. And KD-712 Fully
Automatic Electronic Blood Pressure Monitor is substantially equivalent to the
Fully Automatic Electronic Blood Pressure Monitor KD-738 whose 510(k)
number is K092045.
KD-512 is very similar with its predicate device in the intended use, the design
principle, the material, the performance and the applicable standards. Only
their appearance, the memory time, the display information and the averaging
measurement function are different.
KD-712 is very similar with the predicate device KD-738 in the intended use,
the design principle, the material, the performance and the applicable
standards. Only their appearance, the memory time and the display
information are different.
However, the test in this submission provides demonstration that these small
differences do not raise any new questions of safety and effectiveness to the
new devices.
5. 4
DEPARTMENT OF HEALTH & HUMAN SERVICES Publ IcHealth Ser vice
Pood and Inig Adutin istration

0903 Nc"w l-Ilatpsli ir Awveici
Docum11ent Control1 Room -\V066-G609
Silver Sprting. Nil) 20993-0002
Andon Health Co., Ltd.

C/O Mr. Liu Yi, President
No. 3 Jinping Street Ya'an Road
Nankai District, Tianjin 300190 NOV 3 2010h
China
Re: K 102930
Trade/Device Name: Fully Automatic Electronic Blood Pressure Monitor, Models: KD-5 12,
KD-712
Regulation Number: 21 CFR 870.1130
Regulation Name: Non-Invasive Blood Pressure Measurement System
Regulatory Class: Class II
Product Code: DXN
Dated: Not Dated
Received: October 4, 201 0
Dear Mr. Yi:
We have reviewed your Section 5 10(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind y'ou, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class Ill (PMA), it
may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. Jn addition, FDA may
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
Page 2 - Mr. Liui Yi
comply wvith all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
device-related adverse events) (21 CFR 803); good mtanufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000- 1050.
If you desire specific advice for your device on our labeling regulation (21 CER Part 801), please
go to http://www~N.fda.gov/AboutFDA/CenitersOffices/CD R.lIC DRI-IOffitces/ucnm 115 809.htm for
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please
note the regulation entitled, "Misbranding by reference to preimarket notification" (2ICFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CER Part 803), please go to
http://www.fda. gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number
(800) 638-2041 or (301) 796-71 00 or at its Internet address
hittp://www.fda. pov/MedicalDevices/ResourcesforYou/Industrv/defauilt.htm.
Sincerely yours
Bra DZuckerman, M.D.

Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA 510(k) Files
Statement of Indications for Use NOV - 3 2010
510(k) Number: ________
Device name: KD-512 and KD-712 Fully Automatic Electronic Blood

Pressure Monitor
Indications for use:

Prescription use ______ AND/OR Over-The-Counter Use YES

Part 21 CFR 801 Subpart 0) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON

ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft)g o
Division of Cardiovascular DevicesPaeIoI
510(k) Number________
4-1

510 (K) Summary: C0Ozt

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KD-5l2 and KD-712 Fully Automatic Electronic Blood Pressure Monitor FDA5IO(k) Files

1.0 submitter's information NOV"' ;' 3 201Th.

Name: Andon Health Co., Ltd.

2.0 Device information

Trade name: Fully Automatic Electronic Blood Pressure Monitor

Production code: DXN- Noninvasive blood pressure measurement system.

4.0 Predicate device information

Manufacturer: Andon Health Co., Ltd.

Device: KD-556 Fully Automatic Electronic Blood Pressure

510(k) number: K090963

Manufacturer: Andon Health Co., Ltd.

2Device: KD-738 Fully Automatic Electronic Blood Pressure

__510(k) number: K092045

5.0 Device description

KD-712 Fully Automatic Electronic Blood Pressure Monitor is for use by

It is designed and manufactured according to ANSI/AAMI SP1O--manual,

The operational principle is based on oscillomnetric and silicon integrate

6.0 Intended use

KD-712 Fully Automatic Electronic Blood Pressure Monitor is for use by

7.0 Summary comparing technological characteristics with predicate

Technological Characteristics Comparison result

8.0 Performance summaryI'

KD-512 and KD-712 Fully Automatic Electronic Blood Pressure Monitor

9.0 Comparison to the predicate device and the conclusion

Our device KD-512 Fully Automatic Electronic Blood Pressure Monitor is

Pood and Inig Adutin istration

Andon Health Co., Ltd.

Dear Mr. Yi:

Bra DZuckerman, M.D.

Statement of Indications for Use NOV - 3 2010

510(k) Number: ________

Device name: KD-512 and KD-712 Fully Automatic Electronic Blood

Indications for use:

KD-712 Fully Automatic Electronic Blood Pressure Monitor is for use by

Prescription use ______ AND/OR Over-The-Counter Use YES

(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON

Concurrence of CDRH, Office of Device Evaluation (ODE)

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