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Reusable SpO2 Sensors, Disposable SpO2 Sensors

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K172981Ref A0418-SA129PVRef A1414-SA02Ref A0212-SR203MURef A2520-SW126PURef A0309-SI01Ref A0309-SA102PURef A0816-SA206PV-001Ref A1315-SA242MVRef A0916-SR105PURef A0111-SA02Ref A0111-SA103PVRef A0111-SA01Ref A0314-SA133PURef A1318-SA105PVRef A1424-SP01

by APK Technology Co., Ltd.

Identity

Trade Name
Reusable SpO2 Sensor EUDAMED
Disposable SpO2 sensor EUDAMED
APK FDA UDI
Generic Name
Pulse Co-oximeter probe, single-use FDA UDI
Pulse oximeter probe, reusable FDA UDI
Device Name
Reusable SpO2 Sensor EUDAMED
Disposable SpO2 Sensor EUDAMED
Disposable SpO2 sensor compatible with Nonin Adult sponge FDA UDI
CSI Compatible Reusable SpO2 Sensor FDA UDI
Model / Reference
A1414-SA02 EUDAMEDFDA UDI
A0309-SA102PU EUDAMEDFDA UDI
A0418-SA129PV EUDAMED
A0212-SR203MU EUDAMED
A2520-SW126PU EUDAMED
A0309-SI01 EUDAMED
A0816-SA206PV-001 EUDAMED
A1315-SA242MV EUDAMED
A0916-SR105PU EUDAMED
A0111-SA02 EUDAMED
A0111-SA103PV EUDAMED
A0111-SA01 EUDAMED
A0314-SA133PU EUDAMED
A1318-SA105PV EUDAMED
A1424-SP01 EUDAMED
Description
Disposable SpO2 sensor compatible with Nonin Adult sponge FDA UDI
CSI Compatible Reusable SpO2 Sensor FDA UDI

Identifiers

Primary DI / UDI-DI
06946725524374 EUDAMEDFDA UDI
06946725525784 EUDAMEDFDA UDI
06946725513286 EUDAMED
06946725545263 EUDAMED
06946725529621 EUDAMED
06946725541678 EUDAMED
06946725558164 EUDAMED
06946725538791 EUDAMED
06946725552704 EUDAMED
06946725561058 EUDAMED
06946725556030 EUDAMED
06946725561041 EUDAMED
06946725557150 EUDAMED
06946725538937 EUDAMED
06946725567500 EUDAMED
Basic UDI-DI
69467255A-SPO2-RUV EUDAMED
69467255A-SPO2-DTZ EUDAMED
510(k) Number
K172981 FDA 510(k)
K082846 FDA UDI
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 UDI
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class 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

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDIFDA UDI

Serial Number

No

FDA UDIFDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

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
  • EUDAMED 12609e0a-2a56-4fde-8c7a-109afc091dd5 61 fields · synced Jul 8, 2026
  • 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