# K013171: 3420 Digit Pulse Oximeter, Model 3420

- Pathway: 510(k) (Traditional)
- Applicant: Bci, Inc.
- Decided: Jan 3, 2002 after 101 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 K943404 (1994). 4 ancestors in all.
43 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943404: 3301 Pulse Oximeter, Bci Intl., Inc. (1994) Summary page 1.
- K980714: Bci 3401 Handheld Pulse Oximeter, Bci Intl., Inc. (1998) Summary page 1.
- K942248: Miniaturized Finger Clip Pulse Oximeter, Nonin Medical, Inc. (1994) Summary page 1.
- K001085: Modification to Onyx, Finger Clip Pulse Oximeter, Model 9500, Nonin Medical, Inc. (2000) Summary page 1.

## Most influential descendants
- K043528: Spirotel (2005), 42 descendants of its own
- K061712: Spirobank II (2006), 40 descendants of its own
- K072979: Spirobank G (2007), 33 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own

## Indications for use
The BCI® 3420 Digit™ Pulse Oximeter is a handheld, finger-mounted pulse oximeter that combines the monitor and sensor into one assembly that measures SpO,, pulse rate, and pulse strength. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The BCI 3420 Digit™ Pulse Oximeter will provide reliable measurements on patients ranging from pediatric to adults.

Source page: https://510kreport.com/device/K013171
Methodology: https://510kreport.com/methodology