Atlas FDA

BYE

80 FDA 510(k) clearances · Product code

79 daysmedian time to decision
181 days90th percentile
80clearances measured

FDA profile

Official device name
Attachment, Breathing, Positive End Expiratory Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5965
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2007: 8 · 2008: 3 · 2010: 4 · 2012: 6 · 2014: 8 · 2018: 11
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
Besmed PEEP Valve (K160112)Besmed Health Business Corp2016-04-29
DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE (K133957)Galemed Corp.2014-04-14
B&B BUBBLER (K133210)S & T Medical Technologies, Inc.2014-03-28
PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES (K122610)Sen MU Technology Co., Ltd.2013-08-05
O_TWO CPAP SYSTEM (K112546)O-Two Medical Technologies, Inc.2011-12-27
WATERPAP VALVE (K110713)Airways Development, LLC2011-09-12
NEOPIP PATIENT CIRCUIT WITH PEEP (K103833)Neoforce Group, Inc.2011-04-20
VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 (K092029)Draeger Medical AG & Co. KG2010-08-06
MERCURY CPAP (K090710)Mercury Medical2009-08-20
BABI*PLUS BUBBLE PAP VALVE (K090317)A Plus Medical2009-05-20
MERCURY MEDICAL PEEP VALVE (K081266)Mercury Enterprizes Dba Mercury Medical2009-03-05
PULMODYNE CHF FLOW GENERATOR SYSTEM (K080256)Pulmodyne2008-05-09
NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP (K070416)Neoforce Group, Inc.2007-05-29
KOO AMERICAS VALVE PEEP, MODEL KM-809 (K050918)Koo Americas, Inc.2005-06-06
BOUSSIGNAC C.P.A.P. DEVICE (K013884)Vygon SA2003-01-21
CPAP SYSTEM, MODEL 102001 (K001318)Sims Portex, Inc.2000-07-20
WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH (K982283)Caradyne, Ltd.1999-03-09
EMS PEEP VALVES- ADJUSTABLE (K983920)Engineered Medical Systems1999-01-22
0-20 CM H20 PEEP VALVE (K981415)Cheen Houng Ent. Co. , Ltd.1998-07-14
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 (K963347)Instrumentation Industries, Inc.1997-03-19
SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM (K962492)Nidek Medical Products, Inc.1997-01-23
PEEP VALVE (K961867)Medical Marketing Concepts1996-08-13
WESTMED CIRCULARIE PEP DEVICES (K955047)Westmed Intl.1996-03-27
SIMS CPAP SYSTEM (K953485)Smiths Industries Medical Systems, Inc.1995-10-26
KENDALL SHERIDAN CPAP SYSTEM (K953511)Kendall Healthcare Products Co. Div.Of Tyco Health1995-10-26
SYSTEM 22 VALVE (K950397)Turnkey Intergration USA, Inc.1995-04-14
PURITAN-BENNETT NASAL CPAP MASK (K942246)Puritan-Bennett1994-07-06
SINGLE USE MANUAL RESUSCITATOR PEEP VALVE (K932799)Engineered Medical Systems1993-09-03
AMBU SINGLE PATIENT USE PEEP VALVE (K923976)Ambu, Inc.1993-01-05
PEEP VALVE (K923618)International Respiratory Systems, Inc.1992-08-03
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION (K922178)Puritan Bennett Corp.1992-05-29
20CM/H20 PEEP VALVE (K912578)Vital Signs, Inc.1991-09-11
CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM (K912240)Mallinckrodt Anesthesia Products1991-08-22
ADJUSTABLE PEEP VALVE (K904874)Vital Signs, Inc.1991-01-08
COMPANION 318 NASAL CPAP SYSTEM (K903764)Puritan Bennett Corp.1990-09-10
PEEP VALVE (K902062)Hudson Oxygen Therapy Sales Co.1990-09-04
PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE (K903125)Puritan Bennett Corp.1990-09-04
ONE-LUNG CPAP DEVICE (K901728)Vital Signs, Inc.1990-08-14
RESPIRONICS' REMSTAR(TM) SLEEPEASY (K900113)Respironics, Inc.1990-03-28
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA. (K900164)Puritan Bennett Corp.1990-01-26
LIFECARE NASAL MASK KIT CAT. NO. 06-800 (K894779)Lifecare Services, Inc.1990-01-12
C.P.A.P. VALVE AND C.P.P.A. KIT (K895360)Ballard Medical Products1989-11-15
DEVILBISS MODEL 7351 SERIES (K894424)Devilbiss Health Care, Inc.1989-09-18
CPAP MASK (K894690)Devilbiss Health Care, Inc.1989-09-08
DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM (K893388)Devilbiss Health Care, Inc.1989-06-23
EDENTEC MODEL 2860 PRESSURE METER (K891540)Edentec Corp.1989-06-01
MODIFIED SANDERS BI-PAPEASY (K883825)Respironics, Inc.1988-12-08
P.E.E.P. VALVE (K882219)Life Support Products, Inc.1988-08-30
NASAL CPAP SYSTEM (K881833)Healthdyne, Inc.1988-06-24
SULLIVAN NASAL CPAP SYSTEM (K882292)Baxter Centre For Medical Research1988-06-21
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) (K881614)Ohmeda Medical1988-04-29
ACKRAD PEDIATRIC C.P.A.P. SYSTEM (K880161)Ackrad Laboratories1988-03-04
BREATHE-FREE (K875073)Cincinnati Medical Technologies, Inc.1988-02-29
MC/CPAP MANIFOLD (K874479)Minneapolis Children'S Services Corp.1987-12-30
ARIES (K873170)Mountain Medical Equipment, Inc.1987-09-25
SLEEP APNEA NASAL CPAP SYSTEM (K871693)Puritan Bennett Corp.1987-09-15
ADJUSTABLE PEEP VALVE (K872202)Med Air Technology, Inc.1987-09-01
RESPIRONICS SANDERS BIPAPEASY (K871523)Respironics, Inc.1987-07-16
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA (K861758)Life Design Systems, Inc.1986-07-14
VITAL FLOW NASAL CPAP SYSTEM (K860848)Systems 2000, Inc.1986-06-12
VARIABLE HIGH FLOW DOWNS CPAP GENERATOR (K861104)Med Air Technology, Inc.1986-04-28
LDS PEEP VALVE (K854822)Life Design Systems, Inc.1986-02-24
CUSHION-FLEX TM-CPAP FACE MASK (K854458)Life Design Systems, Inc.1986-01-15
SANDER'S MASKCPAP BY RESPIRONICS (K851396)Respironics, Inc.1985-05-15
AMBU CPAP SYSTEM (K851194)Ambu, Inc.1985-04-15
RESPIRONICS SLEEPEASY NASAL CPAP SYS (K843889)Respironics, Inc.1984-12-04
OHMEDA PEEP VALVE FOR GMS ABSORBER (K843835)Ohmeda Medical1984-11-15
DRAGER PEEP SYSTEM D (K834085)Draeger Medical, Inc.1983-12-16
DOWNS ADJUSTABLE FLOW GENERATOR (K831503)Vital Signs, Inc.1983-09-12
PEEP SYSTEM D (K831301)Draeger Medical, Inc.1983-06-08
PEEPER (K830395)Dupaco, Inc.1983-03-11
PEEP VALVE (K820404)Vital Signs, Inc.1982-03-01
POSITIVE END EXPIRATORY PRESSURE VALVE (K802943)Fraser Harlake, Inc.1981-01-15
DRAGER PEEP CONTROL SYSTEM (K802707)Draeger Medical, Inc.1980-11-12
VITAL SIGNS PEEP VALVE (K802070)Vital Signs, Inc.1980-09-09
BOEHRINGER LABS AMBULATORY PEEP VALVE (K800755)Boehringer Laboratories1980-05-08
VALVE, AMBU PEEP (K782152)Narco Air-Shields1978-12-26
PEEP/CPAP VALVE (K781332)Vickers America Medical Corp.1978-10-04
REGULATOR, PRESSURE, EXPIRATORY (K770766)Globe Safety Products, Inc.1977-05-10
VALVE, PEEP (K760230)Ohio Medical Products1976-08-06

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