# K153291: Sicat Optisleep

- Pathway: 510(k) (Abbreviated)
- Applicant: Sicat GmbH & Co. KG
- Decided: Mar 31, 2016 after 139 days
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K882303 (1989). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113201: Narval CC, Resmed Sas (2011) Summary page 4.
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 4.

## Most influential descendants
- K182661: Kava and Kava with Herbst (2019), 1 descendant of its own
- K221889: ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring (2022), 0 descendants of its own
- K170053: Meridian PM (2017), 0 descendants of its own

## Indications for use
In adult population • To reduce or alleviate snoring • To reduce or alleviate mild to moderate obstructive sleep apnea (OSA)

Source page: https://510kreport.com/device/K153291
Methodology: https://510kreport.com/methodology