# K070732: Bci Autocon 3304 Digital Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Pm, Inc.
- Decided: Jul 9, 2007 after 116 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). 1 ancestor in all.
28 later devices descend from it; 3 cite it directly.
0 of 30 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.

## 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 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits patient monitoring with adjustable alarms limits as well as visible and audible alarm signals.

Source page: https://510kreport.com/device/K070732
Methodology: https://510kreport.com/methodology