iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr
Device Facts
| Record ID | K251113 |
|---|---|
| Device Name | iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr |
| Applicant | Andon Health Co, Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Aug 4, 2025 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
Intended Use
Fully Automatic Electronic Blood Pressure Monitor is 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 15cm-48cm (approx. 5.9"-18.9").
Device Story
The device is a non-invasive, automated electronic blood pressure monitor for adult use in clinical or home settings. It utilizes an inflatable upper arm cuff and an oscillometric pressure sensor to detect arterial pressure oscillations. The device processes these signals to calculate systolic and diastolic blood pressure and pulse rate, and identifies irregular heartbeats. Results are displayed on an integrated LCD/LED screen. Some models include Bluetooth or Wi-Fi connectivity for data transmission. The device is operated by the patient or a healthcare provider. Output allows for monitoring of blood pressure trends, aiding in hypertension management and cardiovascular health assessment.
Clinical Evidence
Clinical study conducted per ISO 81060-2:2018+Amd-1:2020. Enrolled 231 patients (107 male, 124 female). Used standard auscultation as reference with same-arm sequential method. Accuracy verified by meeting criteria 1 and 2 of ISO 81060-2.
Technological Characteristics
Oscillometric measurement with silicon pressure sensor. Powered by DC mains or batteries (AA, AAA, or Li-ion). Dimensions vary by model. Connectivity includes Bluetooth/Wi-Fi or standalone. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 80601-2-30.
Indications for Use
Indicated for adult individuals requiring non-invasive measurement of systolic and diastolic blood pressure and pulse rate via an upper arm cuff (15cm-48cm circumference). Suitable for use by medical professionals or at home.
Regulatory Classification
Identification
A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
Predicate Devices
- Fully Automatic Electronic Blood Pressure Monitor (K234041)
Related Devices
- K210770 — Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor · Andon Health Co, Ltd. · Jul 29, 2021
- K070828 — KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Aug 15, 2007
- K172896 — Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 · Shenzhen Jiacom Technology CO ., Ltd. · Jan 26, 2018
- K234041 — Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS) · Andon Health Co, Ltd. · Apr 22, 2024
- K221913 — Arm Blood Pressure Monitor · Alicn Medical Shenzhen, Inc. · Oct 12, 2022
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
August 4, 2025
Andon Health Co., Ltd.
Liu Yi, President
No. 3 Jin Ping Street
Ya An Road, Nankai District
Tianjin, Tianjin 300190
China
Re: K251113
Trade/Device Name: iHealth Compare Wireless Blood Pressure Monitor (BP-300C);
iHealth Compare Pro Wireless Blood Pressure Monitor (BP-300CV);
iHealth Compare S Wireless Blood Pressure Monitor (BP-300V);
iHealth Wireless Blood Pressure Monitor (BPX1);
iHealth Blood Pressure Monitor (KD-595);
iHealth Track Pro Connected Blood Pressure Monitor (KN-550LT);
Semi Automatic Blood Pressure Monitor (KD-388N);
Arm Blood Pressure Monitor(KD-553);
Arm Blood Pressure Monitor(KD-557BR);
Arm Blood Pressure Monitor(KD-558);
Arm Blood Pressure Monitor(KD-558BR);
Arm Blood Pressure Monitor (KD-5031N);
Arm Blood Pressure Monitor (KD-5810);
Arm Blood Pressure Monitor (KD-5810B);
Arm Blood Pressure Monitor (KD-5811);
Arm Blood Pressure Monitor (KD-5811A);
Arm Blood Pressure Monitor (KD-5811V);
Arm Blood Pressure Monitor (KD-5815);
Arm Blood Pressure Monitor (KD-5920);
Arm Blood Pressure Monitor (KD-5920L);
Arm Blood Pressure Monitor (KD-5920TL);
Arm Blood Pressure Monitor (KD-5923);
iHealth Clear Wireless Blood Pressure Monitor (BPM1)
Regulation Number: 21 CFR 870.1130
Regulation Name: Noninvasive Blood Pressure Measurement System
Regulatory Class: Class II
Product Code: DXN
Dated: July 7, 2025
Received: July 7, 2025
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K251113 - Liu Yi
Page 2
Dear Liu Yi:
We have reviewed your section 510(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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 you, 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 III (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. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 comply with 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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K251113 - Liu Yi
Page 3
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics, and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K251113 | ? |
| Please provide the device trade name(s). | | ? |
| iHealth Compare Wireless Blood Pressure Monitor (BP-300C);
iHealth Compare Pro Wireless Blood Pressure Monitor (BP-300CV);
iHealth Compare S Wireless Blood Pressure Monitor (BP-300V);
iHealth Wireless Blood Pressure Monitor (BPX1);
iHealth Blood Pressure Monitor (KD-595);
iHealth Track Pro Connected Blood Pressure Monitor (KN-550LT);
Semi Automatic Blood Pressure Monitor (KD-388N);
Arm Blood Pressure Monitor (KD-553);
Arm Blood Pressure Monitor (KD-557BR);
Arm Blood Pressure Monitor (KD-558);
Arm Blood Pressure Monitor (KD-558BR);
Arm Blood Pressure Monitor (KD-5031N);
Arm Blood Pressure Monitor (KD-5810);
Arm Blood Pressure Monitor (KD-5810B);
Arm Blood Pressure Monitor (KD-5811);
Arm Blood Pressure Monitor (KD-5811A);
Arm Blood Pressure Monitor (KD-5811V);
Arm Blood Pressure Monitor (KD-5815);
Arm Blood Pressure Monitor (KD-5920);
Arm Blood Pressure Monitor (KD-5920L);
Arm Blood Pressure Monitor (KD-5920TL);
Arm Blood Pressure Monitor (KD-5923);
iHealth Clear Wireless Blood Pressure Monitor (BPM1) | | |
| Please provide your Indications for Use below. | | ? |
| Fully Automatic Electronic Blood Pressure Monitor is 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 noninvasive technique in which an inflatable cuff
is wrapped around the upper arm. The cuff circumference is limited to 15cm-48cm (approx. 5.9"-18.9"). | | |
| Please select the types of uses (select one or both, as
applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
iHealth Compare Wireless Blood Pressure Monitor
Page 8 of 52
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K251113
# 510(k) SUMMARY
(In accordance with 21 CFR 807.92)
## 1.0 Applicant Information
Name: Andon Health Co., Ltd.
Address: No 3, Jinping Street, Ya An Road, Nankai District, Tianjin, 300190, P.R. China
Phone Number: 86-22-87611660
Fax Number: 86-22-87612379
Contact: Mr. Liu Yi
Date of Preparation: 04/11/2025
## 2.0 Device Information
Device Name:
BP-300C: iHealth Compare Wireless Blood Pressure Monitor
BP-300CV: iHealth Compare Pro Wireless Blood Pressure Monitor
BP-300V: iHealth Compare S Wireless Blood Pressure Monitor
BPX1: iHealth Wireless Blood Pressure Monitor
KD-595: iHealth Blood Pressure Monitor
KN-550LT: iHealth Track Pro Connected Blood Pressure Monitor
KD-388N: Semi Automatic Blood Pressure Monitor
KD-553, KD-557BR, KD-558, KD-558BR, KD-5031N, KD-5810, KD-5810B, KD-5811, KD-5811A, KD-5811V, KD-5815, KD-5920, KD-5920L, KD-5920TL, KD-5923: Arm Blood Pressure Monitor
BPM1: iHealth Clear Wireless Blood Pressure Monitor
Page 1 of 10
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K251113
Common Name: Blood Pressure Monitor
Classification Name: Non-Invasive Blood Pressure Measurement System
## 3.0 Classification
Product Code: DXN
Regulation Number: 21 CFR 870.1130
Classification: II
Review Panel: 870 Cardiovascular
## 4.0 Predicate Device Information
Manufacturer: Andon Health Co., Ltd.
Device Name: Fully Automatic Electronic Blood Pressure Monitor
510(k) Number: K234041
Classification: II
Product Code: DXN
## 5.0 Intended Use
Fully Automatic Electronic Blood Pressure Monitor is 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 15cm - 48cm (approx. 5.9" ~ 18.9").
## 6.0 Device Description
Fully Automatic Electronic Blood Pressure Monitor (BP-300C, BP-300CV,
Page 2 of 10
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K251113
BP-300V, BPM1, BPX1, KD-338N, KD-553, KD-557BR, KD-558, KD-558BR, KD-595, KD-5031N, KD-5810, KD-5810B, KD-5811, KD-5811A, KD-5811V, KD-5815, KD-5920, KD-5920L, KD-5920TL, KD-5923, KN-550LT) is designed and manufactured according to IEC 80601-2-30.
The operational principle is based on Oscillo-metric and silicon integrates pressure sensor technology. It can calculate the systolic and diastolic blood pressure and display the result. The measurements results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user.
# 7.0 Comparison of Technological Characteristics with Predicate Device
The following table is the summary of the technological characteristics of the proposed subject device and predicate device.
| Item | Subject Device | Predicate Device Model: KD-5811BT 510(k) No.: K234041 | Comparison Result |
| --- | --- | --- | --- |
| Name and Model | iHealth Compare Wireless Blood Pressure Monitor iHealth Track Pro Connected Blood Pressure Monitor Semi Automatic Blood Pressure Monitor Arm Blood Pressure Monitor BPM1: iHealth Clear Wireless Blood Pressure Monitor | Fully Automatic Electronic Blood Pressure Monitor | -- |
| Intended Use | Fully Automatic Electronic Blood Pressure Monitor is for use by | Fully Automatic Electronic Blood Pressure Monitor is for | The cuff range of subject device is different from the predicate device, but the |
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K251113
| | 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 15cm-48cm (approx. 5.9"-18.9"). | 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 17cm-42cm (approx. 6 11/16"-16 17/32") | clinical report submitted demonstrates that the subject devices are as safe and effective as the predicate device. |
| --- | --- | --- | --- |
| Rx or OTC | OTC | OTC | Same |
| Population | Adult | Adult | Same |
| Cuff Location | Upper arm | Upper arm | Same |
| Physical Attributes | | | |
| Weight (exclude batteries and cuff) | About 328g
About 290g
About 330g
About 200g
About 220g
About 300g
About 211g
About 166g
About 235g
About 221g
About 232g
About 237g
About 239g
About 223g
About 189g
About 225g
About 233g
About 191g
About180g
About 350g | About 239g | The electrical safety report and EMC report submitted demonstrate that the subject devices are as safe and effective as the predicate device. |
| Dimensions | 144.5mm×115mm×60.7mm
136mm×106mm×61mm
98mm×98mm×46mm
153mm×108mm×60mm
136mm×94mm×52mm
165mm×96mm×65mm
138mm×98mm×48mm
107mm×80mm×52mm
150mm×95mm×41mm
139.4mm×93.8mm×43.4 | 139.4mm×93.8mm×43.4mm | The electrical safety report and EMC report submitted demonstrate that the subject devices are as safe and effective as the predicate device. |
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K251113
| | mm
138mm×98mm×48.9mm
136mm×120mm×61mm
136mm×100mm×64mm
139.4mm×93.8mm×41.8mm
119mm×118mm×51mm | | |
| --- | --- | --- | --- |
| Memory | 2×360 times
1×99 times
120 times
1×60 times
1×90 times
2×60 times
4×30 times
2×120 times
2×200 times | 2×120 times | The software validation report submitted demonstrates the subject device are as safe and effective as the predicate device. |
| Displayed Calculated Parameters | SYS
DIA
Pulse
IHB | SYS
DIA
Pulse
IHB | Same |
| Display component | LCD with backlight
LCD without backlight
LED without backlight | LCD With backlight | The electrical safety report submitted demonstrates that the subject devices are as safe and effective as the predicate device. |
| Average function | The average value of the last three results in the current user memory zone
The average value in the morning of this week. It can display the morning average data from the 1 to 10 weeks ago.
The average value of all the readings for the selected user
The average value of all the readings for the selected user
The average value of all the results which are measured from 5 o'clock to 9 o'clock in the last 7 days
The average value of all the results which are measured from 18 o'clock to 20 o'clock in the last 7 days
No Average function | 1. The average value of the last three results in the current user memory zone
2. The average value of all the readings for the selected user
3. The average value of all the results which are measured from 5 o'clock to 9 o'clock in the last 7 days
4. The average value of all the results which are measured from 18 o'clock to 20 o'clock in the last 7 days | Average functions are not core functions and key performance. The subject devices are as safe and effective as the predicate device in achieving its intended use. |
| Other display information | All Models:
Battery usage | Battery usage | Same |
| | Date/ Time | Date/ Time | Display “Date/ Time” are not the core functions and key |
5 / 10
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K251113
| | None | | performance. The subject devices are as safe and effective as the predicate device in achieving its intended use. |
| --- | --- | --- | --- |
| | Blood pressure level None | Blood pressure level | Display “Blood pressure level” are not the core functions and key performance. The subject devices are as safe and effective as the predicate device in achieving its intended use. |
| | Cuff wrap “OK” symbol Cuff wrap “loose” symbol None | Cuff wrap “OK” symbol | Show the cuff wrap symbol in different with predicate device have been validated, the software validation report submitted demonstrates the subject device are as safe and effective as the predicate device.
Display “Cuff wrap symbol” are not the core functions and key performance. The subject devices which do not display this information are as safe and effective as the predicate device in achieving its intended use. |
| | Body movement symbol None | Body movement symbol | Display “Body movement symbol” are not the core functions and key performance. The devices do not display this information are as safe and effective as the predicate device in achieving its intended use. |
| | Bluetooth symbol None | Bluetooth symbol | The other models do not have Bluetooth function do not display this information. |
| | Status Marking None | None | The models which have added status marking display compared with predicate device have been software validated. The software validation report submitted demonstrates these devices are as safe and effective as the predicate device. |
| Wireless Function | Bluetooth Wi-Fi None | Bluetooth | The model which has a different wireless function with predicate device have been tested. The software validation report and wireless coexistence testing report submitted demonstrates the device is as safe and effective |
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K251113
| | | | as the predicate device. Wireless function are not the core functions and key performance. The models do not have wireless function are as safe and effective as the predicate device in achieving its intended use. |
| --- | --- | --- | --- |
| Sound indication Function | Sound indication function None | None | The models which added sound indication function compared with predicate device have been tested. The software validation report submitted demonstrates these devices are as safe and effective as the predicate device. |
| Electrical Power | | | |
| DC Mains | 5V
6V:
No Medical AC adapter | 5V | The models whose DC Mains are different with the predicate device have been tested. The electrical safety test report and EMC test report demonstrate these devices are as safe and effective as the predicate device. |
| Battery | 4×1.5V SIZE AA
4×1.5V SIZE AAA
3×1.5V SIZE AA
1*3.7V Li-ion 1200mAh
1*3.7V Li-ion 2200mAh
1*3.7V Li-ion 1800mAh | 4×1.5V SIZE AA | The models whose battery are different with predicate device have been tested. The electrical safety test report and EMC test report demonstrate the subject device are as safe and effective as the predicate device. |
| Operation Limitation | | | |
| Temperature | 5~40°C | 5~40°C | Same |
| Humidity | ≤85% RH | ≤85% RH | Same |
| Storage Limitation | | | |
| Temperature | -20°C to 55°C | -20°C to 55°C | Same |
| Humidity | ≤90% RH | ≤90% RH | Same |
| Performance Parameter | | | |
| Pulse rate | 40-180 times/min | 40-180 times/min | Same |
| Pulse rate accuracy | Less than 60: ±3bpm
More than 60 (incl.): ±5% | Less than 60: ±3bpm
More than 60 (incl.): ±5% | Same |
| Technique Method | Oscillo-metric | Oscillo-metric | Same |
| Measure process | Measure during deflating
Measure during inflating | Measure during deflating | The models whose measure process are different from the predicate device have been tested, the clinical |
Page 7 of 10
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K251113
| | | | investigation report submitted demonstrates that the subject devices are as safe and effective as the predicate device. |
| --- | --- | --- | --- |
| Systolic Range | 60-260 mmHg | 60-260 mmHg | Same |
| Diastolic Range | 40-199 mmHg | 40-199 mmHg | Same |
| Pressure Accuracy | Within ±3 mmHg | Within ±3 mmHg | Same |
| Cuff pressure Range | 0-300 mmHg | 0-300 mmHg | Same |
| Over pressure Limit | 300 mmHg | 300 mmHg | Same |
| Algorithm | Oscillometric | Oscillometric | Same |
There are no significant differences between the subject device and the predicate device. They are identical in terms of intended use, materials, design, and manufacturing methods.
# 8.0 Discussion of Non-Clinical Testing
Non-clinical tests were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device complies with the following standards:
- IEC 60601-1:2005+AMD1: 2012+AMD2: 2020, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
- IEC 60601-1-2:2014+AMD1: 2020, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests.
Page 8 of 10
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K251113
- IEC 60601-1-11: 2015+AMD1: 2020, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 80601-2-30: 2018, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.
The tests above demonstrate that the subject devices do not raise new questions of safety and effectiveness as compared to the predicate device.
## 9.0 Discussion of Clinical Testing
Comparison and evaluation are carried out between the subject device and cleared devices, and it shows that:
The clinical study was conducted in accordance with ISO 81060-2:2018+Amd-1:2020. A total of 231 patients (107 males and 124 females) were enrolled in the study, standard auscultation method was used as the reference blood pressure monitor measuring, the same arm sequential method was chosen. Accuracy of the blood pressure monitors was verified by meeting criteria 1 and criteria 2 of ISO 81060-2.
## 10.0 Comparison to the Predicate Device and Conclusion
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K251113
The conclusion drawn from the nonclinical tests and clinical test demonstrate that the subject devices are substantially equivalent to the predicate device.
The subject devices are very similar to the predicate device in the intended use, design principle, materials, performance and applicable standards. Their appearance, memory capacity, display information, Electrical Power are different. However, the tests in this submission demonstrate that these differences do not raise any new questions of safety and effectiveness. And the subject device is as safe, effective and performs as well or better than the legally marketed predicate device.
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