# K962865: Rembrandt System

- Pathway: 510(k) (Traditional)
- Applicant: Airsep Corp.
- Decided: Oct 25, 1996 after 94 days
- Product code: FLS (Monitor, Apnea, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.2377
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
98 later devices descend from it; 3 cite it directly.
0 of 99 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
- K041904: Compass F10 System (2004), 54 descendants of its own
- K073682: Embletta Gold (2008), 41 descendants of its own
- K041724: Compass M10 System (2004), 41 descendants of its own
- K061405: Apnealink, Model 22302 (2006), 30 descendants of its own
- K070263: Apnealink (2007), 29 descendants of its own

Source page: https://510kreport.com/device/K962865
Methodology: https://510kreport.com/methodology