Atlas FDA

MNS

47 FDA 510(k) clearances · Product code

130 daysmedian time to decision
267 days90th percentile
47clearances measured

FDA profile

Official device name
Ventilator, Continuous, Non-Life-Supporting
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5895
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 256 · 2022: 2,514 · 2023: 1,320 · 2024: 1,571 · 2025: 1,810 · 2026: 3,183
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
myAir (K251889)Resmed Corp2026-04-08
BreathePal Bilevel (GFM50-MD2201) (K252078)Compal Electronics, Inc.2026-03-17
Mariana Minerva; Mariana Nimbus (K251661)Resmed Pty , Ltd.2026-02-23
Vivo 1, Vivo 2 (K240778)Breas Medical AB2024-12-13
ReddyPort Elbow (K231064)Smd Manufacturing, LLC2023-07-13
BPAP System (K213169)BMC Medical Co., Ltd.2022-12-05
ReddyPort NIV Access Elbow (K171827)Smd Manufacturing, LLC2018-01-19
Juno VPAP ST-A (K161492)Resmed, Ltd.2017-01-19
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (K161487)Resmed, Ltd.2016-09-09
Juno VPAP ST-A (K153061)Resmed, Ltd.2016-04-13
EASYCARE ONLINE (K132371)Resmed, Ltd.2013-11-22
S9 VPAP TX (K123511)Resmed, Ltd.2013-03-21
EASYCARE ONLINE (K123557)Resmed, Ltd.2013-03-14
VPAP S-A (K122324)Resmed, Ltd.2012-11-13
VPAP TX (K113714)Resmed, Ltd.2012-05-25
VPAP ST-A (K113288)Resmed, Ltd.2012-03-29
RESSCAN (K113815)Resmed, Ltd.2012-03-27
BIPAP A 30 VENTILATORY SUPPORT SYSTEM (K113053)Respironics, Inc.2012-02-01
VPAP TX (K112914)Resmed, Ltd.2011-12-29
OXIMETRY INTERFACE KIT (K111378)Philips Respironics, Inc.2011-10-04
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K102465)Respironics, Inc.2011-03-24
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK (K101130)Respironics, Inc.2010-09-02
VPAP III ST-A (K093731)Resmed, Ltd.2010-03-22
DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES (K093070)Sunrise Medical2010-01-26
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K092818)Respironics, Inc.2010-01-22
VPAP TX (K092186)Resmed, Ltd.2009-12-22
BIPAP AUTOSV ADVANCED (K090539)Respironics Inc., Sleep & Home Respiratory Group2009-10-30
BIPAP SYNCHRONY 2 (K092043)Respironics, Inc.2009-08-05
BIPAP AUTOSV (K090248)Respironics Inc., Sleep & Home Respiratory Group2009-03-04
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM (K071509)Respironics Inc., Sleep & Home Respiratory Group2007-08-08
BIPAP SYNCHRONY WITH AVAPS (K070328)Respironics Inc., Sleep & Home Respiratory Group2007-05-08
BIPAP AUTOSV (K063540)Respironics, Inc.2007-02-22
BIPAP SYNCHRONY (K063533)Respironics, Inc.2007-02-20
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30 (K060546)Breas Medical AB2006-05-26
VPAP III ST-A/KIDSTA MASK SYSTEM (K060105)Resmed, Ltd.2006-04-07
BIPAP FOCUS (K053168)Respironics (Ireland) Limited2006-01-04
VPAP ADAPT (K051364)Resmed, Ltd.2005-08-16
VPAP III ST-A (K033276)Resmed, Ltd.2004-06-07
NASAL-AIR CRITICAL CARE (K031896)Innomed Technologies2004-01-14
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM (K031656)Respironics, Inc.2003-07-30
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX (K020777)Respironics, Inc.2002-03-20
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM (K012323)Respironics, Inc.2001-12-20
BIPAP SYNCHRONY HC (K992530)Respironics, Inc.2000-03-20
BIPAP HARMONY S/T, MODEL 1001445 (K984407)Respironics, Inc.1999-05-19
SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM (K974417)Resmed Corp1998-06-24
MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV (K962517)Healthdyne Technologies, Inc.1997-02-20
PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM (K942210)Puritan Bennett Corp.1996-02-09

Track MNS automatically

Every clearance here is in the API, with alerts when new ones post.