Atlas FDA

CAP

78 FDA 510(k) clearances · Product code

66 daysmedian time to decision
276 days90th percentile
78clearances measured

FDA profile

Official device name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2600
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 1 · 2001: 1 · 2003: 1 · 2004: 2 · 2005: 2 · 2006: 2
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
SINGLE USE MANOMETER (K201666)Flexicare Medical Limited.2020-11-13
VORTRAN APM-Plus (K182292)Vortran Medical Technology 1, Inc.2019-09-18
NS 120P-TRS Airway Pressure Gauge (K180510)Instrumentation Industries, Inc.2019-05-01
NAPA LP-15 Airway Pressure Monitor (K172284)Drw Medical, LLC2018-02-09
VORTRAN Manometer (K153733)Vortran Medical Technology 1, Inc.2016-09-16
Disposable Pressure Manometer (DPM) (K143148)Westmed, Inc.2015-08-11
DISPOSABLE PRESSURE MANOMETER (K140370)Besmed Health Business Corp2014-06-19
GIO DIGITAL PRESSURE GUAGES (K122627)Galemed Corp.2013-08-22
MANOMETER (K122077)Intersurgical, Inc.2013-01-10
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (K120118)Ventlab Corp.2012-05-24
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC (K103639)Vortran Medical Technology 1, Inc.2011-09-15
PRESSURE MANOMETER (K110119)Neoforce Group, Inc.2011-06-10
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 (K102377)A Plus Medical2010-11-18
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (K081778)Instrumentation Industries, Inc.2008-09-12
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 (K050309)Viasys Medsystems2005-03-25
AMBU DISPOSABLE PRESSURE MANOMETER (K040991)Ambu, Inc.2004-07-22
DISPOSABLE PRESSURE MANOMETER (K022402)Vital Signs, Inc.2002-08-22
DISPOSABLE PRESSURE MONITOR (K003497)Engineered Medical Systems2000-11-30
CRITERION 60 OR PM 60 (K000959)Caradyne, Ltd.2000-06-22
CRITERION 40 OR PM 40 (K992101)Caradyne, Ltd.2000-01-06
TSX PRM PULMONARY RESUSCITATION MONITOR (K973347)Spiracle Technology1998-07-23
1ST RESPONSE DISPOSABLE MANOMETER (K961318)Intertech Resources, Inc.1996-12-17
MERCURY AIRWAY PRESSURE MANOMETER (K954486)Mercury Medical1996-04-25
AMS 3000M (K936009)Acutronic Medical Systems AG1995-05-03
PORTA-RESP MONITOR (K943146)S & M Instrument Co.1994-11-28
MICRO MPM (K940375)Micro Direct, Inc.1994-11-21
CM5000R REMOTE INDICATOR (K931394)Canadian Monaghan , Ltd.1993-07-01
CM7000 REMOTE INDICATOR (K931287)Canadian Monaghan , Ltd.1993-07-01
AIRWAY PRESSURE MONITOR CM 5000 NGAN (K925673)Canadian Monaghan , Ltd.1993-06-09
BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE (K921978)Core-M, Inc.1992-11-17
RESPIRONICS' DIGITAL MANOMETER (K904935)Respironics, Inc.1991-04-03
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.) (K902276)Respironics, Inc.1990-08-17
PENLON BREATHING SYSTEM PRESSURE MONITOR (K902381)Penlon, Inc.1990-08-17
INFANT C.P.A.P. MONITOR (K896136)Hudson Oxygen Therapy Sales Co.1990-01-09
VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR (K895747)Hudson Oxygen Therapy Sales Co.1989-10-27
LIFECARE PRESSURE ALARM CAT. NO. 34-010 (K894361)Lifecare Services, Inc.1989-10-05
PENLON IDP PRESSURE FAILURE ALARM (K894689)Penlon, Inc.1989-08-10
BREATH TRACKER (K892942)Core-M, Inc.1989-06-23
CM 7000MR (K890010)Trudell Medical1989-06-12
CM 5000R REMOTE AIRWAY PRESSURE (K873953)Canadian Monaghan , Ltd.1987-10-27
M-1 PRESSURE MONITOR (K871336)Bio-Med Devices, Inc.1987-06-05
M-10 VENTILATION MONITOR (K871139)Bio-Med Devices, Inc.1987-04-21
CM 5000 MONITOR AIRWAY PRESSURE (K871083)Canadian Monaghan , Ltd.1987-04-08
OHMEDA 5500 AIRWAY PRESSURE MONITOR (K864536)Ohmeda Medical1987-01-12
MODIFIED BAROMED BREATHING PRESSURE MONITOR (K861720)Draeger Medical, Inc.1986-05-09
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600 (K861330)Sechrist Industries, Inc.1986-04-11
VENTILATOR PRESSURE ALARM MODEL VPA-100 (K854934)Respiratory Support Products, Inc.1985-12-24
AN PRESSURE MONITOR (K852826)Ferguson Medical1985-12-03
PMA PRESSURE MONITOR (K852824)Ferguson Medical1985-12-03
LPA-2 REMOTE ALARM (K851905)Life Products, Inc.1985-07-08
AIRWAY PRESSURE MONITOR (K840420)Respiratory Support Products, Inc.1984-04-05
DRAGER BAROMED (K840279)Draeger Medical, Inc.1984-03-02
EMERSON MODEL 3MV-AP AND 3V-AP PRESS- (K832271)J. H. Emerson Co.1983-09-12
MONAGHAN'S PRESSURE ALARM (K821649)Monaghan Medical Corp.1982-08-05
SINGLE USE NON-CONDUCTIVE CIRC. DISCON (K821667)Vital Signs, Inc.1982-06-24
RESPIRATOR MONITOR (K820720)Rv Systems1982-04-26
MONITRON MODEL JL-7 (K820353)Florida Medical Equipment Repair, Inc.1982-03-12
EAST VENTILARM PRESSURE MONITOR ALARM S. (K812960)Cairco , Ltd.1981-11-16
VENTI-MONITOR MODEL 101 (K812041)Medix Medical Electronics (U.S.A.), Inc.1981-09-25
BIRD MEAN AIRWAY PRESSURE MONITOR (K812140)3M Company1981-08-20
AIRWAY PRESSURE MONITOR (K810753)Impact Instrumentation, Inc.1981-03-31
SECHRIST AIRWAY PRESSURE MONITOR #400 (K810648)Sechrist Industries, Inc.1981-03-20
BLSI VENTILATION MONITOR (K810547)Bunnell Life Systems, Inc.1981-03-11
MEAN PRESSURE MONITOR (K810255)Healthdyne, Inc.1981-02-12
MONITOR, AIRWAY PRESSURE (K802955)Novametrix Medical Systems, Inc.1980-12-19
TRAVENOL ULTRASONIC NEBULIZER CUPS (K802054)Travenol Laboratories, S.A.1980-12-01
3MP-7 SCANNER RESPIRATORY MONITOR (K802565)Bird Products Corp.1980-10-31
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC (K802090)Draeger Medical, Inc.1980-09-26
PENLON I.D.P. PRESSSURE FAILURE ALARM (K801254)Penlon, Inc.1980-06-09
RESPIRATOR DISCONNECT ALARM CR 201 (K792516)Intersect Medical Products, Inc.1980-01-09
RESPIRATOR DISCONNECT ALARM (K792515)Intersect Medical Products, Inc.1980-01-09
RESPIRATOR DISCONNECT ALARM CR201 (K791527)Intersect Medical Products, Inc.1979-09-19
RESPIRATOR DISCONNECT ALARM VA-100 (K791561)Intersect Medical Products, Inc.1979-09-19
BUNN MODEL #40 LOW PRESSURE ALARM (K790370)The John Bunn Co.1979-03-28
PRESSURE ALARM (K782174)Thompson Respiration Products, Inc.1979-01-22
PNEUMOGARD MODEL 1230 (K781714)Novametrix Medical Systems, Inc.1978-11-27
PRESSURE, LOW/HIGH MODEL C1070 (K781697)Timeter Instrument Corp.1978-10-27
MODEL 65 HIGH & LOW PRESSURE ALARM (K780863)The John Bunn Co.1978-08-21

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