# Sleepnet Corporation

- Location (FDA's records): Hampton, NH
- FDA decisions: 23 (1996–2026): 23 510(k) clearances
- Product codes: BZD (18), CBK (4), BTT (1)
- 510(k) review time since 2016: median 129 days, against 203 for FDA's reviews in the same codes and years (9 of 10 faster)
- Predicates its devices cite: 28 (15 its own); citations of its devices by later devices: 22 (15 its own)
- Recalls linked to its devices: 7 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Resmed, Ltd.: 5 (https://510kreport.com/company/resmed)
- Respironics, Inc.: 3 (https://510kreport.com/company/respironics)
- Respironics Inc., Sleep & Home Respiratory Group: 2 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Innomed Technologies, Inc./Respcare, Inc.: 1 (https://510kreport.com/company/innomed-technologies-respcare)
- Airways Ltd., Inc.: 1 (https://510kreport.com/company/airways)
- Tiara Medical Systems, Inc.: 1 (https://510kreport.com/company/tiara-medical-systems)

## Firms that cite its devices most
- Resmed, Ltd.: 2 (https://510kreport.com/company/resmed)
- Draeger Medical, Inc.: 2 (https://510kreport.com/company/draeger-medical)
- Invacare Corp.: 1 (https://510kreport.com/company/invacare)
- Vital Signs, Inc.: 1 (https://510kreport.com/company/vital-signs)
- Dcstar, Inc.: 1 (https://510kreport.com/company/dcstar)

## Its most-cited devices
- K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837 (2006), cited by 4
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented (2007), cited by 3
- K021534: IQ Nasal Mask, Model 50160 Rev. D (2002), cited by 2
- K090935: Minime Pediatric Mask (2009), cited by 2
- K102317: IQ Ventilation Nasal Mask (2011), cited by 2
- K993269: IQ Nasal Mask, Model P/N 50160 (1999), cited by 2

## Recent decisions
- K251847: Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (Jan 15, 2026)
- K241830: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (Oct 18, 2024)
- K241943: Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask (Aug 28, 2024)
- K241661: Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask (Jul 10, 2024)
- K241520: Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask (Jun 27, 2024)
- K241469: iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask (Jun 15, 2024)
- K211274: iQ 2 Nasal Mask, Phantom 2 Nasal Mask (Jan 10, 2022)
- K203601: Innova Nasal Non-Vented Mask (Apr 30, 2021)

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