Caremed
The filing describes the Caremed sensors as containing two light-emitting diodes that serve as light sources and a photodiode that acts as a light detector. The components are held in the…
The filing describes the Caremed sensors as containing two light-emitting diodes that serve as light sources and a photodiode that acts as a light detector. The components are held in the sensor housing.
The filing names models C403-01, C403S-15 and N543-01. It describes them as Nellcor adult reusable finger clip, Masimo adult reusable soft tip and Nellcor adult disposable non-adhesive sensors, respectively.
Listed Item
Caremed Disposable SpO2 Sensors
Sensor Models and Monitoring
Their stated use is continuous, non-invasive monitoring of arterial hemoglobin oxygen saturation and pulse rate in adults over 40 kg and pediatric patients weighing 10 to 50 kg at hospital facilities.
Who Else Makes It
Concentrated in Guangdong (46), Jiangsu (7), Beijing (5). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Measurement Specialties Chengdu | Chengdu | Sichuan | Contract manufacturer | 3 |
| Beijing Kingst Commercial & Trade Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Showing 12 of 70. All 70 manufacturers in China registered for Oximeter
Record
| Listed by | Shenzhen Caremed Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | DQA |
| Device type | Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K153184 |
| Record published | 2026-07-09 |
| Record revised | 2024-09-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2019-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA30B-29 | In distribution | |
| Reusable | In distribution | |
| C503-49 | In distribution | |
| C523-16 | In distribution | |
| SA20B-08 | In distribution | |
| SA10B-127 | In distribution | |
| C903-91 | In distribution | |
| C403S-49R | In distribution | |
| H8-CF103 | In distribution | |
| SA30B-09 | In distribution | |
| C103F-49R | In distribution | |
| SA30S-91 | In distribution | |
| SA10B-01 | In distribution | |
| SA30B-07 | In distribution | |
| C410B-15R | In distribution | |
| C430B-146D | In distribution | |
| SA30B-48R | In distribution | |
| C533-16 | In distribution | |
| C503-16 | In distribution | |
| SA10B-75 | In distribution | |
| C403-01 | In distribution | |
| SA30B-02 | In distribution | |
| C803-01X | In distribution | |
| SA36B-15R | In distribution | |
| C410B-153R | In distribution | |
| SA30B-20 | In distribution | |
| C403B-117 | In distribution | |
| SA20B-91 | In distribution | |
| SA36B-15 | In distribution | |
| C403B-01X | In distribution | |
| SA15B-49R | In distribution | |
| SA30B-43X | In distribution | |
| SA30B-21 | In distribution | |
| SA30B-48 | In distribution | |
| C403S-15 | In distribution | |
| C543-16 | In distribution | |
| C803-49R | In distribution | |
| SA30Y-01X | In distribution | |
| SA30B-300 | In distribution | |
| SA30C-01X | In distribution | |
| H8-CF101 | In distribution | |
| N543-01 | In distribution | |
| SA30B-08 | In distribution | |
| SA30B-75 | In distribution | |
| SA10B-08 | In distribution | |
| SA15B-91 | In distribution | |
| C410-21X | In distribution | |
| SA30B-01X | In distribution | |
| C503-01 | In distribution | |
| C403B-49R | In distribution | |
| SA30B-91 | In distribution | |
| SA30B-21R | In distribution | |
| SA36B-15* | In distribution | |
| SA11Y-49 | Withdrawn | |
| SA30Y-15R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 2,838 |
| APK | APK Technology Co., Ltd. | 2,678 |
| ChoiceMMed | Beijing Choice Electronic Technology Co., Ltd. | 151 |
| Nellcor | Covidien LP | 138 |
| Nonin | Nonin Medical, Inc. | 129 |
| Orantech | Orantech Inc. | 97 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 93 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 66 |
| Medichoice | Owens & Minor Distribution, Inc. | 62 |
| Sensoronics | Sensoronics Incorporated | 53 |
| Virtuox | Healthcare Logistics Systems | 36 |
| AMC | LifeSync Corporation | 36 |
Showing 12 of 1,063. All products under Oximeter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191279 | 2019-12-06 |
| K153184 | 2017-01-04 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Nihon Kohden America, Inc. | UDI-DI | 2024-09-18 | Class II | No Marketing Application | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | 67 |
| Nihon Kohden America, Inc. | UDI-DI | 2024-09-18 | Class II | No Marketing Application | Due to oximeters not having FDA market approval or clearance to distribute in the U.S. | 64 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.