# K991410: 3402 Handheld Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Jun 9, 1999 after 48 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 K962156 (1996). 2 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962156: 3304 Pulse Oximeter, Bci Intl., Inc. (1996) Summary page 1.
- K980714: Bci 3401 Handheld Pulse Oximeter, Bci Intl., Inc. (1998) Summary page 1.

## Most influential descendants
- K083705: Bci WW1020 Pulse Oximeter, Model WW1020 (2009), 25 descendants of its own
- K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103 (2010), 22 descendants of its own
- K142832: Unimed Disposable and Reusable SPO2 Sensors (2015), 14 descendants of its own
- K153184: Caremed Reusable & Disposable SPO2 Sensors (2017), 5 descendants of its own
- K242580: Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (2025), 1 descendant of its own

## Indications for use
The 3402 Digital Handheld Oximeter is a handheld, low cost pulse oximeter for spot checking or continuous roonitoring of SpO,, pulse rate, and pulse strength. It may be used in all critical environments, including clinical and EMS (Emergency Medical Services), patient ground transport, and for use in sleep screening or in the home. The oximetry parameter works with all BCI oximetry sensors, providing SpO, and pulse rate on all patients from neonate to adult. The 3402 Digital Handheld Oximeter permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. The BCI 3402 is not designed or intended to be used as an apnea monitor.

Source page: https://510kreport.com/device/K991410
Methodology: https://510kreport.com/methodology