# K943404: 3301 Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Bci Intl., Inc.
- Decided: Oct 13, 1994 after 91 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.
44 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013171: 3420 Digit Pulse Oximeter, Model 3420 (2002), 43 descendants of its own
- 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

Source page: https://510kreport.com/device/K943404
Methodology: https://510kreport.com/methodology