FDA Product Code
FDA Product Code MNS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5895
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251889 | myAir | Resmed Corp | 2026-04-08 | Traditional | PDF ↗ |
| K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | 2026-03-17 | Traditional | PDF ↗ |
| K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | 2026-02-23 | Traditional | PDF ↗ |
| K240778 | Vivo 1, Vivo 2 | Breas Medical AB | 2024-12-13 | Traditional | PDF ↗ |
| K231064 | ReddyPort Elbow | Smd Manufacturing, LLC | 2023-07-13 | Traditional | PDF ↗ |
| K213169 | BPAP System | BMC Medical Co., Ltd. | 2022-12-05 | Traditional | PDF ↗ |
| K171827 | ReddyPort NIV Access Elbow | Smd Manufacturing, LLC | 2018-01-19 | Traditional | PDF ↗ |
| K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017-01-19 | Traditional | PDF ↗ |
| K161487 | VPAP Adapt SV, VPAP Tx, S9 VPAP Tx | Resmed, Ltd. | 2016-09-09 | Traditional | PDF ↗ |
| K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016-04-13 | Traditional | PDF ↗ |
| K132371 | EASYCARE ONLINE | Resmed, Ltd. | 2013-11-22 | Traditional | PDF ↗ |
| K123511 | S9 VPAP TX | Resmed, Ltd. | 2013-03-21 | Traditional | PDF ↗ |
| K123557 | EASYCARE ONLINE | Resmed, Ltd. | 2013-03-14 | Traditional | PDF ↗ |
| K122324 | VPAP S-A | Resmed, Ltd. | 2012-11-13 | Traditional | PDF ↗ |
| K113714 | VPAP TX | Resmed, Ltd. | 2012-05-25 | Traditional | PDF ↗ |
| K113288 | VPAP ST-A | Resmed, Ltd. | 2012-03-29 | Traditional | PDF ↗ |
| K113815 | RESSCAN | Resmed, Ltd. | 2012-03-27 | Traditional | PDF ↗ |
| K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2012-02-01 | Abbreviated | PDF ↗ |
| K112914 | VPAP TX | Resmed, Ltd. | 2011-12-29 | Traditional | PDF ↗ |
| K111378 | OXIMETRY INTERFACE KIT | Philips Respironics, Inc. | 2011-10-04 | Traditional | PDF ↗ |
| K102465 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2011-03-24 | Traditional | PDF ↗ |
| K101130 | BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK | Respironics, Inc. | 2010-09-02 | Special | PDF ↗ |
| K093731 | VPAP III ST-A | Resmed, Ltd. | 2010-03-22 | Traditional | PDF ↗ |
| K093070 | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES | Sunrise Medical | 2010-01-26 | Traditional | PDF ↗ |
| K092818 | BIPAP AVAPS VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2010-01-22 | Traditional | PDF ↗ |
| K092186 | VPAP TX | Resmed, Ltd. | 2009-12-22 | Traditional | PDF ↗ |
| K090539 | BIPAP AUTOSV ADVANCED | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-30 | Traditional | PDF ↗ |
| K092043 | BIPAP SYNCHRONY 2 | Respironics, Inc. | 2009-08-05 | Special | PDF ↗ |
| K090248 | BIPAP AUTOSV | Respironics Inc., Sleep & Home Respiratory Group | 2009-03-04 | Special | PDF ↗ |
| K071509 | BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM | Respironics Inc., Sleep & Home Respiratory Group | 2007-08-08 | Special | PDF ↗ |
| K070328 | BIPAP SYNCHRONY WITH AVAPS | Respironics Inc., Sleep & Home Respiratory Group | 2007-05-08 | Traditional | PDF ↗ |
| K063540 | BIPAP AUTOSV | Respironics, Inc. | 2007-02-22 | Abbreviated | PDF ↗ |
| K063533 | BIPAP SYNCHRONY | Respironics, Inc. | 2007-02-20 | Abbreviated | PDF ↗ |
| K060546 | BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 | Breas Medical AB | 2006-05-26 | Traditional | PDF ↗ |
| K060105 | VPAP III ST-A/KIDSTA MASK SYSTEM | Resmed, Ltd. | 2006-04-07 | Traditional | PDF ↗ |
| K053168 | BIPAP FOCUS | Respironics (Ireland) Limited | 2006-01-04 | Traditional | PDF ↗ |
| K051364 | VPAP ADAPT | Resmed, Ltd. | 2005-08-16 | Traditional | PDF ↗ |
| K033276 | VPAP III ST-A | Resmed, Ltd. | 2004-06-07 | Traditional | PDF ↗ |
| K031896 | NASAL-AIR CRITICAL CARE | Innomed Technologies | 2004-01-14 | Traditional | PDF ↗ |
| K031656 | BIPAP HARMONY VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2003-07-30 | Special | PDF ↗ |
| K020777 | BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX | Respironics, Inc. | 2002-03-20 | Special | PDF ↗ |
| K012323 | BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM | Respironics, Inc. | 2001-12-20 | Special | PDF ↗ |
| K992530 | BIPAP SYNCHRONY HC | Respironics, Inc. | 2000-03-20 | Abbreviated | PDF ↗ |
| K984407 | BIPAP HARMONY S/T, MODEL 1001445 | Respironics, Inc. | 1999-05-19 | Abbreviated | PDF ↗ |
| K974417 | SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM | Resmed Corp | 1998-06-24 | Traditional | PDF ↗ |
| K962517 | MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV | Healthdyne Technologies, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K942210 | PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM | Puritan Bennett Corp. | 1996-02-09 | Traditional | PDF ↗ |
Product code MNS · Class II · Anesthesiology. Data: openFDA.