BCI 3401 Handheld Pulse Oximeter
by Bci Intl., Inc. 510(k)
Active
510(k) K980714
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980714 | Date25 Mar 1998 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 1 Oct 2026
The BCI 3401 Handheld Pulse Oximeter is a portable device designed for non-invasive monitoring of oxygen saturation (SpO₂), pulse rate, and pulse strength. Classified as a pulse oximeter, it measures these vital signs by detecting light absorption through peripheral tissue, typically via a sensor placed on a finger or earlobe. This handheld unit is intended for use in clinical and non-clinical settings to provide real-time patient monitoring, including neonatal to adult populations. Its compact design allows for easy transport and deployment in various environments.
The device is supplied as a reusable unit powered by four AA alkaline batteries and includes an integrated printer for recording measurements. It features red LEDs for easy visibility of readings and a rubber boot for protection. The BCI 3401 is intended for attended monitoring and spot readings, with no explicit indication of sterility requirements in its specifications. Regulatory clearance under the FDA 510(k) pathway (K980714) confirms its compliance with U.S. medical device standards, though no additional details on MRI safety or specific storage conditions are provided.
Other devices from Bci Intl., Inc.
Questions
AI-generated answers, 1 Oct 2026
What vital signs does the BCI 3401 Handheld Pulse Oximeter measure?
The BCI 3401 measures oxygen saturation (SpO₂), pulse rate, and pulse strength. It achieves this through non-invasive light absorption detection via a sensor placed on a finger or earlobe, making it suitable for monitoring patients from neonates to adults.
How is the BCI 3401 Handheld Pulse Oximeter powered and supplied?
The device is supplied as a reusable unit and operates using four AA alkaline batteries. Its compact design and battery power make it portable for easy transport and use in various environments, including clinical and non-clinical settings.
Does the BCI 3401 Handheld Pulse Oximeter have any sterility requirements?
The device does not specify explicit sterility requirements in its specifications. It is intended for attended monitoring and spot readings, so handling practices should follow standard clinical protocols to ensure patient safety.
What features does the BCI 3401 Handheld Pulse Oximeter include for ease of use?
The BCI 3401 includes an integrated printer for recording measurements, red LEDs for easy visibility of readings, and a rubber boot for protection. These features enhance usability and reliability during monitoring.
Is the BCI 3401 Handheld Pulse Oximeter approved for specific regulatory pathways?
The device holds FDA 510(k) clearance under the traditional pathway (K980714), confirming compliance with U.S. medical device standards. This approval ensures it meets regulatory requirements for non-invasive pulse oximetry.