Pulse Oximeter
by Bci Intl., Inc. 510(k)
Active
510(k) K941289
Overview
A pulse oximeter is a non-invasive device used to measure oxygen saturation (SpO2) and pulse rate in patients. It operates by transmitting light through tissue and detecting changes in light absorption to determine arterial oxygen levels.
This device is intended for use in clinical and home settings for monitoring oxygenation status. It is supplied as a reusable or single-use sensor component depending on the model, with no indication of sterility or MRI safety provided in the data. The device received FDA 510(k) clearance under K941289 and is classified under product code DQA.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK941289 | Date22 Jun 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bci Intl., Inc.
Questions
What is a pulse oximeter used for?
A pulse oximeter is a non-invasive device used to measure oxygen saturation (SpO2) and pulse rate in patients. It helps monitor oxygenation status in both clinical and home settings by transmitting light through tissue and detecting absorption changes.
How is the pulse oximeter supplied?
The device is supplied as either a reusable or single-use sensor component depending on the model. The data does not specify sterility or MRI safety information for any of the available models.
What regulatory approval does this pulse oximeter have?
This pulse oximeter received FDA 510(k) clearance under K941289 and is classified under product code DQA. It was determined to be substantially equivalent to other devices in this category.
Where can this pulse oximeter be used?
The device is intended for use in both clinical and home settings for monitoring oxygenation status. It can be used by healthcare professionals in medical facilities or by patients for at-home monitoring of their oxygen levels and pulse rate.