# Wesper, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 4 (2021–2026): 4 510(k) clearances
- Product codes: MNR (3), DQA (1)
- 510(k) review time since 2016: median 255 days, against 205 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shenzhen Viatom Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-viatom-technology)
- Embla Systems: 1 (https://510kreport.com/company/embla-systems)
- Mycardio, LLC Dba Sleepimage.: 1 (https://510kreport.com/company/mycardio-dba-sleepimage)

## Its most-cited devices
- K203343: Wesper Lab (2021), cited by 1

## Recent decisions
- K252628: Cassie (Apr 27, 2026)
- K221816: Wesper Lab (Mar 9, 2023)
- K213515: WesperO2 (Jun 10, 2022)
- K203343: Wesper Lab (Dec 21, 2021)

Source page: https://510kreport.com/company/wesper