# K930790: Addition of Built-in Oxymeter to Sleepscan Prod.

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Jan 6, 1994 after 324 days
- Product code: BZQ (Monitor, Breathing Frequency)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
46 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962103: Bio-Logic Sleepscan Product with Built-in Oximeter (1996), 45 descendants of its own
- K012437: Devilbiss Sleep Recorder Model # RM60 (2002), 42 descendants of its own
- K040595: ALICE 5 (2004), 40 descendants of its own
- K112102: Michele Sleep Scoring Systems (2011), 18 descendants of its own
- K120450: Sleep Profiler (2012), 16 descendants of its own

Source page: https://510kreport.com/device/K930790
Methodology: https://510kreport.com/methodology