# Zephyr Sleep Technologies

- Location (FDA's records): Calgary, CA
- FDA decisions: 7 (2012–2020): 6 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Zephyr Sleep Technologies (5); Zephyr Sleep Technologies, Inc. (2)
- Product codes: MNR (4), LRK (2), QCJ (1)
- 510(k) review time since 2016: median 129 days, against 192 for FDA's reviews in the same codes and years (5 of 5 faster)
- Predicates its devices cite: 9 (4 its own); citations of its devices by later devices: 4 (4 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
- Advanced Brain Monitoring, Inc.: 2 (https://510kreport.com/company/advanced-brain-monitoring)
- Frantz Design, Inc.: 1 (https://510kreport.com/company/frantz-design)
- Demetech Corp.: 1 (https://510kreport.com/company/demetech)
- Resmed Germany, Inc.: 1 (https://510kreport.com/company/resmed-germany)

## Its most-cited devices
- DEN170090: MATRx plus (2018), cited by 1
- K163665: MATRx plus (2017), cited by 1
- K181996: MATRx Plus (2018), cited by 1
- K191925: MATRx Plus (2019), cited by 1

## Recent decisions
- K200695: MATRx plus (Aug 24, 2020)
- K191925: MATRx Plus (Oct 29, 2019)
- K190051: TD Clip (Jun 7, 2019)
- K181996: MATRx Plus (Nov 21, 2018)
- DEN170090: MATRx plus (Aug 23, 2018)
- K163665: MATRx plus (May 5, 2017)
- K103704: Remotely Controlled Mandibular Positioner, RCMP (Mar 23, 2012)

Source page: https://510kreport.com/company/zephyr-sleep-technologies