Reusable SpO2 Sensors, Disposable SpO2 Sensors
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Reusable SpO2 Sensor EUDAMEDDisposable SpO2 sensor EUDAMEDAPK FDA UDI
- Generic Name
- Pulse Co-oximeter probe, single-use FDA UDIPulse oximeter probe, reusable FDA UDI
- Device Name
- Reusable SpO2 Sensor EUDAMEDDisposable SpO2 Sensor EUDAMEDDisposable SpO2 sensor compatible with Nonin Adult sponge FDA UDICSI Compatible Reusable SpO2 Sensor FDA UDI
- Model / Reference
- A1414-SA02 EUDAMEDFDA UDIA0309-SA102PU EUDAMEDFDA UDIA0418-SA129PV EUDAMEDA0212-SR203MU EUDAMEDA2520-SW126PU EUDAMEDA0309-SI01 EUDAMEDA0816-SA206PV-001 EUDAMEDA1315-SA242MV EUDAMEDA0916-SR105PU EUDAMEDA0111-SA02 EUDAMEDA0111-SA103PV EUDAMEDA0111-SA01 EUDAMEDA0314-SA133PU EUDAMEDA1318-SA105PV EUDAMEDA1424-SP01 EUDAMED
- Description
- Disposable SpO2 sensor compatible with Nonin Adult sponge FDA UDICSI Compatible Reusable SpO2 Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946725524374 EUDAMEDFDA UDI06946725525784 EUDAMEDFDA UDI06946725513286 EUDAMED06946725545263 EUDAMED06946725529621 EUDAMED06946725541678 EUDAMED06946725558164 EUDAMED06946725538791 EUDAMED06946725552704 EUDAMED06946725561058 EUDAMED06946725556030 EUDAMED06946725561041 EUDAMED06946725557150 EUDAMED06946725538937 EUDAMED06946725567500 EUDAMED
- Basic UDI-DI
- 69467255A-SPO2-RUV EUDAMED69467255A-SPO2-DTZ EUDAMED
- FDA Product Code
- DQA FDA 510(k)FDA UDI
- EMDN Code
- C900301 PULSE OXIMETER SENSORS EUDAMED
- GMDN Term
- Pulse Co-oximeter probe, single-use FDA UDIPulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Reusable SpO₂ Sensors and Disposable SpO₂ Sensors are pulse oximetry sensors designed for non-invasive monitoring of oxygen saturation in blood (SpO₂). These devices adhere to the nomenclature for Pulse Oximeter Sensors and function by emitting light through a patient’s finger, earlobe, or other peripheral site to measure hemoglobin oxygenation levels.
These sensors are supplied in reusable and disposable configurations, intended for use in clinical, hospital, or home monitoring settings. The reusable sensors are designed for multiple uses with appropriate cleaning and sterilization, while the disposable sensors are intended for single-use applications. Both variants comply with FDA 510(k) and MDR regulatory requirements, ensuring adherence to safety and performance standards for medical device applications.
Frequently asked questions
What are the key differences between the reusable and disposable SpO₂ sensors from APK Technology Co., Ltd.?
The reusable SpO₂ sensors are designed for multiple uses with proper cleaning and sterilization, making them cost-effective for clinical or hospital settings where sensors are frequently reused. In contrast, the disposable sensors are intended for single-use only, offering convenience and reducing the risk of cross-contamination in home or clinical settings. Both types serve the same purpose—non-invasive monitoring of blood oxygen saturation—but their design caters to different operational needs.
How are these SpO₂ sensors regulated, and what does that mean for their use in clinical settings?
These sensors are cleared under the FDA’s 510(k) pathway and comply with the Medical Device Regulation (MDR), ensuring they meet established safety and performance standards. The clearance type is traditional, meaning the manufacturer demonstrated substantial equivalence to a predicate device already on the market. This regulatory route confirms their suitability for clinical, hospital, or home monitoring of oxygen saturation, but users should follow manufacturer guidelines for cleaning, sterilization (for reusable models), and proper handling to maintain accuracy and safety.
Can I use the reusable SpO₂ sensors on multiple patients, and if so, what precautions should I take?
Yes, the reusable sensors are explicitly designed for multiple uses with appropriate cleaning and sterilization between patients. To ensure safety and accuracy, follow the manufacturer’s instructions for disinfection and sterilization—typically involving cleaning with approved agents and sterilization methods like autoclaving or chemical sterilization. Proper maintenance prevents contamination and degradation of sensor performance, which is critical for reliable SpO₂ readings in clinical or home settings.
Are these sensors compatible with all pulse oximeters, or do I need to check compatibility before purchasing?
While the sensors are designed for general use with pulse oximeters that adhere to standard pulse oximetry sensor nomenclature, compatibility can vary depending on the specific oximeter model. It’s best to verify compatibility with your existing equipment or consult APK Technology’s documentation or technical support to ensure seamless integration. This step avoids potential issues with signal quality or functionality, which could affect monitoring accuracy.
How should I store the disposable SpO₂ sensors to maintain their sterility and functionality?
The disposable sensors should be stored in their original, sealed packaging until use to preserve sterility and prevent contamination. Keep them in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture, as these conditions can degrade the sensor’s performance. Always check the packaging for expiration dates or integrity before use to ensure reliability and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: reusable - Wiktionary, the free dictionary
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K172981 | Class II | Active |
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Manufacturer
- Manufacturer
- APK Technology Co., Ltd.
Sources (18)
- FDA 510(k) K172981 24 fields · synced Sep 30, 2026
- FDA UDI 659ffca5-0e21-4e03-876a-a72b83adc741 34 fields · synced May 30, 2026
- FDA UDI 25fc62a7-5e22-41a2-a13d-833a79149d1f 34 fields · synced May 30, 2026
- EUDAMED cf254457-8724-4755-9ca3-9a9b3e825692 61 fields · synced Jul 8, 2026
- EUDAMED 3acdc1f1-633f-427c-aff3-64dda15574df 61 fields · synced Jul 8, 2026
- EUDAMED 45d94b2f-4043-4726-82bc-abd31e294af5 61 fields · synced Jul 8, 2026
- EUDAMED 78861cff-fc90-48db-b956-3404a0153b16 61 fields · synced Jul 8, 2026
- EUDAMED a45c0952-f7a0-4ec1-ae0f-66d75003c8c6 61 fields · synced Jul 8, 2026
- EUDAMED 007341b3-be2c-4850-adae-5a8cabae4253 61 fields · synced Jul 8, 2026
- EUDAMED e30eebe9-7886-440d-a68c-d27818ac7ec7 61 fields · synced Jul 8, 2026
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- EUDAMED db41c3b4-5e18-4efa-94a3-b2c9a6410eca 61 fields · synced Jul 8, 2026
- EUDAMED cac1a826-ac5b-4525-b9d1-594a7246cc2f 61 fields · synced Jul 10, 2026
- EUDAMED 42639b97-364d-4d15-8701-6273c3d623c3 61 fields · synced Jul 16, 2026
- EUDAMED 2f67729d-b832-4c71-9528-0b3a086be564 61 fields · synced Jul 28, 2026
- EUDAMED 06807247-84b7-443a-a8b3-ea3047fffce1 61 fields · synced Aug 1, 2026
- EUDAMED 0d7c301a-895f-4afb-acec-caa18c440df4 61 fields · synced Sep 17, 2026
- EUDAMED 1ef94832-0bfc-4580-9449-17f8f2229810 61 fields · synced Sep 30, 2026