Fingertip Pulse Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Fingertip Pulse Oximeter EUDAMED
- Model / Reference
- BSX253,BSX233,BSX251,BSX255B,BSX238B,BSX231 EUDAMEDREF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920485307729 EUDAMED
- Basic UDI-DI
- 69204853BSXQ3R7 EUDAMED
- 510(k) Number
- K202324 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
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
Yes
Incorporates Medicinal Product
No
The Fingertip Pulse Oximeter is a non-invasive medical device classified as a pulse oximeter, designed to measure oxygen saturation (SpO₂) in arterial blood and pulse rate by placing a sensor on a fingertip. It provides real-time, continuous monitoring of these vital signs, enabling quick assessment of a patient’s oxygenation status and circulatory function.
This device is intended for single-use or reusable applications in clinical and home settings, depending on the model variant. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance under the Cardiovascular advisory committee and complies with MDD and MDR directives. The device is non-magnetic and safe for use in non-MRI environments, with no specified size constraints beyond standard fingertip sensor dimensions.
Frequently asked questions
What are the key differences between the single-use and reusable variants of this pulse oximeter, and how should I decide which to use?
The Fingertip Pulse Oximeter is designed for either single-use or reusable applications, depending on the model variant. Single-use models are ideal for clinical settings where infection control is critical, such as hospitals or outpatient clinics, as they eliminate the need for cleaning and reprocessing. Reusable models are better suited for home use or environments where the device will be shared among multiple patients over time, provided proper cleaning and maintenance are followed. The choice depends on your setting’s infection control protocols and patient population.
How do I know if the device I receive is sterile or non-sterile, and what does that mean for its use?
The Fingertip Pulse Oximeter can be supplied either sterile or non-sterile, depending on the specific model variant. Sterile versions are packaged in a way that maintains a germ-free state and are intended for direct patient use without additional preparation, such as in surgical or critical care settings. Non-sterile versions are not intended for invasive procedures or direct contact with sterile fields and may require cleaning before reuse. Always check the packaging or documentation included with the device to confirm sterility status.
Can I use this pulse oximeter in an MRI environment, and if not, why?
No, this Fingertip Pulse Oximeter is explicitly labeled as safe for use only in non-MRI environments. The device is marked as non-magnetic, but it is not designed or tested for compatibility with MRI systems, which involve strong magnetic fields and radiofrequency waves. Using it in an MRI environment could pose risks to both the device and the patient, so it should only be used in areas where MRI procedures are not conducted.
What regulatory pathways has this device gone through, and what does that mean for its use in clinical settings?
The Fingertip Pulse Oximeter has undergone FDA 510(k) clearance through the Cardiovascular advisory committee, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) directives. This means the device has been evaluated for safety and performance by regulatory bodies and is considered substantially equivalent to legally marketed devices in the U.S. and compliant with European Union standards. Clinicians can rely on its regulatory clearance as evidence of its intended use for measuring oxygen saturation and pulse rate in non-invasive monitoring.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202324 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen BSX Technology Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K202324 24 fields · synced Sep 18, 2026
- EUDAMED a88cc8cb-87bc-4bb4-8952-4de81d178d8c 61 fields · synced Jul 13, 2026