# K190058: PureSleep (OTC use)

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Science Partners, Inc.
- Decided: Apr 11, 2019 after 90 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
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 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 no predicate by number.

## Most influential descendants
- K220688: SilentZPro 2.0 (2022), 1 descendant of its own
- K213088: ZQuiet Advance (2022), 1 descendant of its own
- K253868: QuietLab Pro (2025), 0 descendants of its own
- K250028: Anti Snore Mouthpiece (2025), 0 descendants of its own
- K222475: Snor Lock (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K190058
Methodology: https://510kreport.com/methodology