Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
Device Facts
| Record ID | K252655 |
|---|---|
| Device Name | Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) |
| Applicant | Shenzhen Imdk Medical Technology Co., Ltd. |
| Product Code | DQA · Cardiovascular |
| Decision Date | May 11, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2700 |
| Device Class | Class 2 |
Indications for Use
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the fingertip. This portable device is indicated for use in adult patients in hospitals, professional healthcare facilities, and home environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse.
Device Story
Portable fingertip pulse oximeter; measures functional oxygen saturation (SpO2) and pulse rate (PR). Uses red (660nm) and infrared (905nm) light-emitting diodes and a light-electronic transducer to detect pulse-modulated light absorption. Hardware and software process signals to calculate SpO2 and PR; displays values, plethysmographic (PLETH) curve, pulse amplitude, and battery status. Used by clinicians or patients for spot checks in hospitals, clinics, or home settings. Not for continuous monitoring, motion, or low perfusion states. Provides numerical data to assist in clinical assessment of oxygenation status.
Clinical Evidence
Clinical hypoxia study conducted per ISO 80601-2-61 on 12 healthy adult volunteers (5 female, 7 male) with varying skin pigmentation (including 3 dark-skinned subjects, Fitzpatrick V-VI). Primary endpoint: SpO2 accuracy (ARMS) vs. co-oximetry. Results: Overall ARMS of 2.10% across 70-100% range. Subgroup analysis (light, medium, dark skin) showed no systematic bias or significant performance degradation. Study exceeded 200 data points.
Technological Characteristics
Fingertip-mounted pulse oximeter; LED wavelengths: 660nm (red), 905nm (infrared). Power: 2x AAA 1.5V batteries. Materials: Biocompatible per ISO 10993-1. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-61. Connectivity: Standalone. Software: Embedded firmware for signal processing and display.
Indications for Use
Indicated for adult patients in hospitals, professional healthcare facilities, and home environments for non-invasive spot checking of functional oxygen saturation (SpO2) and pulse rate (PR). Not indicated for continuous monitoring, use during motion, or use with low perfusion.
Regulatory Classification
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Predicate Devices
- Pulse Oximeter, Model: C101H1 (K173123)
Reference Devices
- Pulse Oximeter, Model: C101A2, C101B1, C101A3 (K221979)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 11, 2026
Shenzhen IMDK Medical Technology Co., Ltd.
% Boyle Wang
General Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K252655
Trade/Device Name: Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
Regulation Number: 21 CFR 870.2700
Regulation Name: Oximeter
Regulatory Class: Class II
Product Code: DQA
Dated: April 3, 2026
Received: April 3, 2026
Dear Boyle Wang:
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252655 - Boyle Wang
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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.
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.
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K252655 - Boyle Wang
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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,
Bradley Q. Quinn -S
Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| 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. | K252655 | ? |
| Please provide the device trade name(s). | | ? |
| Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) | | |
| Please provide your Indications for Use below. | | ? |
| The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the fingertip. This portable device is indicated for use in adult patients in hospitals, professional healthcare facilities, and home environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion. The device is intended for reuse. | | |
| 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) | ? |
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510(k) Summary
# 510(k) Summary
# K252655
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
## 1.0 Submitter's Information
Name: Shenzhen IMDK Medical Technology Co., Ltd.
Address: 904, 9F, Guangming Tianan Cloud Park Building, 255 Zhenmei Road, Zhenmei Community, Xinhu Street, Guangming District, Shenzhen, 518107, PEOPLE'S REPUBLIC OF CHINA.
Tel: +86-755-27155684
Contact: Ms. Yuan Xia
Registration Number: 3015007456
## Designated Submission Correspondent
Contact: Mr. Boyle Wang
Name: Shanghai Truthful Information Technology Co., Ltd.
Address: Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China
Tel: +86-21-50313932
Email: Info@truthful.com.cn
Date of Preparation: March.25th, 2026
## 2.0 Device Information
Trade name: Pulse Oximeter
Common name: Pulse Oximeter
Classification name: Oximeter
Model(s): PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT
Production code: DQA
Regulation number: 21 CFR 870.2700
Classification: Class II
Panel: Anesthesiology
## 3.0 Predicate & Reference Device Information
### Predicate#
Manufacturer: Shenzhen IMDK Medical Technology Co., Ltd.
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510(k) Summary
Trade name: Pulse Oximeter, Model: C101H1
510(k) number: K173123
## Reference#
Manufacturer: Shenzhen IMDK Medical Technology Co., Ltd.
Trade name: Pulse Oximeter, Model: C101A2, C101B1, C101A3
510(k) number: K221979
K221979 is only being used as a reference device for the materials it is made of and the biocompatibility testing associated with it.
## 4.0 Indication for Use Statement
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the fingertip. This portable device is indicated for use in adult patients in hospitals, professional healthcare facilities, and home environments.
The device is not intended for continuous monitoring, use during motion or use with low perfusion.
The device is intended for reuse.
## 5.0 Device Description
These Pulse Oximeters intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR). The device measures SpO2 and PR with a SpO2 sensor and can display the SpO2, pulse rate, Pulse Amplitude Index and other indication parameters, such as pulse amplitude bar and battery power status on the display screen. SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. These pulse oximeter, models PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT, are designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment.
This medical device can be reused. It is used for adult patients without motions.
Not for continuously monitoring.
## 6.0 Technological Characteristic Comparison Table
Table1-General Comparison
| Item | Subject Device K252655 | Predicated Device K173123 | Remark |
| --- | --- | --- | --- |
| Product Name | Pulse Oximeter | Pulse Oximeter | -- |
| Manufacturer | Shenzhen IMDK Medical Technology | Shenzhen IMDK Medical Technology | -- |
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510(k) Summary
Table 2 Performance Comparison
| Item | Subject Device K252655 | Predicate Device K173123 | Remark |
| --- | --- | --- | --- |
| LED wavelength | Red= 660 nm; Infrared=905nm | Red= 660nm; Infrared= 905nm | Same |
| Power source | DC3.0V(2*AAA 1.5V batteries ) | 2 AAA alkaline batteries | Same |
| SpO2 Display Range | 0-99% | 0%-100% | Similar |
| SpO2 Measuring Range | 35%-100% | 0%-100% | Different |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 80~100%, ±2%; 70%~79%, ±3%; 0% to 69%: unspecified | 70~100%, ±3%; | Different |
| PR Measuring Range | 30bpm-240 bpm | 30bpm-240 bpm | Same |
| PR Resolution | 1 bpm | 1 bpm | Same |
| PR Accuracy | ± 3bpm | ±1 bpm or ±1%, whichever is greater | Different |
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510(k) Summary
# Analysis:
The differences in $\mathrm{SpO}_2$ measuring range and $\mathrm{SpO}_2$ accuracy, and PR accuracy between the Subject Device and Predicate Device do not affect the intended use, technological characteristics, or safety/effectiveness profile of the device. Both devices comply with the applicable requirements of ISO 80601-2-61:2017 and the FDA pulse oximeter guidance.
The Subject Device is therefore substantially equivalent to the Predicate Device.
Table 3 Safety Comparison
| Item | Subject Device K252655 | Predicate Device K173123 | Remark |
| --- | --- | --- | --- |
| Electrical Safety | Comply with IEC 60601-1 IEC 60601-1-11 | Comply with IEC 60601-1 IEC 60601-1-11 | Same |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Performance | ISO 80601-2-61 | ISO 80601-2-61 | Same |
| Biocompatibility | Comply with ISO 10993-1, FDA Guidance | Comply with ISO 10993-1, FDA Guidance | Same |
# 7.0 Non-clinical Testing Summary
The following performance data have been conducted to verify that the Oximeter meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
# Conclusions for Biocompatibility Testing
The biocompatibility evaluation for the oximeter was conducted in accordance with the FDA's Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process'", as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of permanent (>30 days).
Biocompatibility testing for the subject device leverages the biocompatibility data from the reference device (K221979), which has the same patient-contacting materials and contact characteristics.
The reference device K221979 is used specifically to support the material characterization and associated biocompatibility testing. Therefore, no additional biocompatibility testing was required for the subject device.
# Electrical and EMC Safety:
The electrical safety and EMC safety testing was performed to, and passed, the following standards:
IEC 60601-1:2005/AMD2:2020, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
IEC 60601-1-11:2020, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard:
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510(k) Summary
Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-2:2020, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62471:2006, Photobiological safety of lamps and lamp systems
## Summary of Bench Testing
Bench testing was conducted and the results show that the subject device complies with the below standard:
- ISO 80601-2-61:2018, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
## Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Content of Premarket Submissions for Device Software Functions.
The Software Validation is in compliance with FDA Guidance.
## Summary of Shelf Life and Cleaning Testing
The service life has been verified through accelerated aging. The service life is 3 years except the battery is reasonable and effective.
Cleaning and disinfection validation testing was conducted in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the User manual.
## 8.0 Clinical Test Summary
The clinical study was conducted in accordance to ISO 80601-2-61. The subject device of this study was to verify the accuracy of pulse oximetry (SpO2) measured by the oximeter (model PO-H1AO) with a measurement range of 70-100% under no motion on 12 healthy adult volunteers, in which 5 females and 7 males.
Clinical hypoxia test results were obtained in human adult volunteers (the study population includes sufficient darkly pigmented subjects) to validate the accuracy of the subject devices versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Twelve subjects were enrolled for the clinical study. The Fitzpatrick Scale and Monk's Scale were used to determine their skin pigmentation scores. 3 dark subjects (Fitzpatrick Type 5-6/Monk Type 08-09) in this study allow a proper
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510(k) Summary
evaluation of the sensor accuracy in dark population. The study contains more than the minimum 200 data points, and the clinical study results support device accuracy claims for the specified saturation range.
The overall $\mathrm{SpO}_2$ accuracy performance of the subject device demonstrated an ARMS of $2.10\%$ during steady state conditions over the range of $70 - 100\%$.
Subgroup analyses were conducted to evaluate potential bias and performance differences with respect to gender and skin pigmentation (light, medium, and dark).
For skin pigmentation subgroups:
- Dark skin subjects (Fitzpatrick V–VI) demonstrated ARMS values of approximately 2.05–2.10% over the 70–100% range.
- Medium skin subjects (Fitzpatrick IV) demonstrated ARMS values of approximately $2.10\%$.
- Light skin subjects (Fitzpatrick I–III) demonstrated ARMS values ranging from approximately $1.48\%$ to $2.33\%$.
Bias analysis across all subgroups showed no systematic deviation that would indicate reduced performance in any specific population group.
The clinical study results support that the device is safe and effective for use across the intended patient population.
## 9.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the subject device is substantially equivalent to the legally marketed predicated device.
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