# K962156: 3304 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Aug 28, 1996 after 85 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
No predicates in its family tree.
40 later devices descend from it; 8 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BCI 3301 Oximeter: named in the summary without a submission number
- (no number) BCI 3302 Oximeter: named in the summary without a submission number
- (no number) BCI 3100 Oximeter: named in the summary without a submission number

## Most influential descendants
- K070732: Bci Autocon 3304 Digital Pulse Oximeter (2007), 28 descendants of its own
- K991410: 3402 Handheld Pulse Oximeter (1999), 28 descendants of its own
- 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

## Indications for use
The 3304 provides fast, reliable SpO,, 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 continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

Source page: https://510kreport.com/device/K962156
Methodology: https://510kreport.com/methodology