# K020350: Bci 3180 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bci, Inc.
- Decided: Apr 30, 2002 after 85 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K893877 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K962156: 3304 Pulse Oximeter, Bci Intl., Inc. (1996) Summary page 1.
- K980714: Bci 3401 Handheld Pulse Oximeter, Bci Intl., Inc. (1998) Summary page 1.

## Recalls of this device
- Jan 15, 2010 · Not classified · Z-0919-2010: Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 
- Feb 27, 2008 · Not classified · Z-1619-2008: The Smith Medical PM, Inc. BCI 3180 Pulse Oximeter tantalum capacitors C38, C72, C74, and C98 were installed backwards during assembly at the board manufacturer. This exposes the components to reverse

## Indications for use
The BCI 3180 pulse oximeter is indicated for continuous petient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BCI pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.

Source page: https://510kreport.com/device/K020350
Methodology: https://510kreport.com/methodology