# K020739: Bci 3178 Pediatric Pulse Oximetry Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Bci, Inc.
- Decided: Jun 3, 2002 after 89 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K893877 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893877: Biochem 3100 Oximeter, Biochem International, Inc. (1989) Summary page 1.
- K901861: Biochem 9100 Multigas Monitor, Biochem International, Inc. (1990) Summary page 1.

## Indications for use
The BCI 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used to non-invasively measure oxygen saturation (SpO2), pulse rate and plethysmographic pulse waves. It's performance was validated with the BCI 3304 pulse oximeter. The BCI 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 lbs (5 - 45 kg). The sensor is not intended for prolonged use.

Source page: https://510kreport.com/device/K020739
Methodology: https://510kreport.com/methodology