# Resmed, Ltd.

- Location (FDA's records): San Diego, CA
- FDA decisions: 126 (1996–2026): 126 510(k) clearances
- Names in FDA's records: Resmed, Ltd. (103); Resmed Corp (18); Resmed Pty , Ltd. (3); Resmed Sas (2)
- Product codes: BZD (97), MNS (19), CBK (4), BTT (2), MQC (1), LQZ (1), MNT (1), MOD (1)
- 510(k) review time since 2016: median 159 days, against 217 for FDA's reviews in the same codes and years (13 of 23 faster)
- Predicates its devices cite: 217 (195 its own); citations of its devices by later devices: 296 (195 its own)
- Recalls linked to its devices: 13 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Resmed Germany, Inc.: 4 (https://510kreport.com/company/resmed-germany)
- Respironics, Inc.: 3 (https://510kreport.com/company/respironics)
- Somnomed, Inc.: 2 (https://510kreport.com/company/somnomed)
- Sleepnet Corporation: 2 (https://510kreport.com/company/sleepnet)
- Rescare, Ltd.: 2 (https://510kreport.com/company/rescare)
- Hommed, LLC: 2 (https://510kreport.com/company/hommed)
- Pulmonetic Systems, Inc.: 1 (https://510kreport.com/company/pulmonetic-systems)
- Hans Rudolph, Inc.: 1 (https://510kreport.com/company/hans-rudolph)

## Firms that cite its devices most
- Respironics, Inc.: 9 (https://510kreport.com/company/respironics)
- BMC Medical Co., Ltd.: 6 (https://510kreport.com/company/bmc-medical)
- Sleepnet Corporation: 5 (https://510kreport.com/company/sleepnet)
- Breas Medical AB: 5 (https://510kreport.com/company/breas-medical)
- Hans Rudolph, Inc.: 5 (https://510kreport.com/company/hans-rudolph)
- Sunrise Medical, Inc.: 5 (https://510kreport.com/company/sunrise-medical)
- Vital Signs, Inc.: 4 (https://510kreport.com/company/vital-signs)
- 3B Medical, Inc.: 3 (https://510kreport.com/company/3b-medical)

## Its most-cited devices
- K050359: Ultra Mirage II Mask (2005), cited by 13
- K023244: Mirage Full Face Mask Series 2 (2002), cited by 12
- K961783: Sullivan Vpap II ST Nasal Vpap System (1996), cited by 11
- K042403: Mirage Swift (2004), cited by 9
- K060105: Vpap Iii ST-a/Kidsta Mask System (2006), cited by 8
- K090244: Swift FX (2009), cited by 7

## Recent decisions
- K261360: EasyCare Tx 2 (Aug 27, 2026)
- K253553: Orion (Jun 4, 2026)
- K254104: ResScan Essentials (May 27, 2026)
- K251889: myAir (Apr 8, 2026)
- K251661: Mariana Minerva; Mariana Nimbus (Feb 23, 2026)
- K251657: Personalized Therapy Comfort Settings (PTCS) (Dec 5, 2025)
- K250624: myAir (May 28, 2025)
- K242547: AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)

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