Atlas FDA

CAN

55 FDA 510(k) clearances · Product code

66 daysmedian time to decision
202 days90th percentile
55clearances measured

FDA profile

Official device name
Regulator, Pressure, Gas Cylinder
Device class
Class I (low risk)
Regulation
21 CFR 868.2700
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2017: 11 · 2018: 238 · 2019: 20 · 2023: 19 · 2024: 59 · 2026: 17
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
MR Conditional CGA 870 (K162811)Essex Industries, Inc.2017-03-02
PORTABLE OXYGEN UNIT SCA900 (K080243)San Cheong Co. , Ltd.2009-04-07
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (K060265)Remcore, Inc.2006-10-25
CYL-FIL OXYGEN SYSTEM (K061785)Responsive Respiratory, Inc.2006-09-07
OXYGEN REGULATOR (K950777)Mada Medical Products, Inc.1995-04-14
VANGUARD SERIES GAS REGULATORS (K942751)Buckman Co., Inc.1995-02-09
LSPI PRESSURE REGULATOR (K936187)Life Support Products, Inc.1994-01-27
1500 SERIES REGULATOR (K932006)Precision Medical, Inc.1993-10-25
AMBU OXYGEN REGULATOR (K921125)Amg, LLC1992-09-17
GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (K915154)C.G.H. Medical, Inc.1992-05-27
REGULATOR FLOWMETER (K915505)Lifeguard Medical Products, Inc.1992-04-22
GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) (K914271)C.G.H. Medical, Inc.1992-04-13
SALTER LABS DISPOSABLE NIPPLE AND NUT (K912174)Salter Labs1991-07-24
PRECISION MEDICAL OXYGEN REGULATOR (K901831)Precision Medical, Inc.1990-08-14
AMBU OXYGEN REGULATOR (K901623)Flotec, Inc.1990-04-26
RX02 EMERGENCY MEDICAL OXYGEN (K895956)Progressive Medical Applications Corp.1990-04-05
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B (K900115)Ventlab Corp.1990-02-22
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW. (K896152)Puritan Bennett Corp.1990-01-09
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR (K896128)Puritan Bennett Corp.1990-01-09
8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI (K894850)Modern Engineering Co., Inc.1989-08-31
OXYGEN THERAPY REGULATOR (K894302)Modern Engineering Co., Inc.1989-08-07
CONCOA PRESSURE REGULATORS (K893621)Concoa Controls Corp. of America1989-07-28
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER (K884927)Instrumentation Industries, Inc.1989-06-23
VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED (K891771)Thermadyne Holings Corp.1989-06-23
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR (K883483)Autoflow Products, Co.1988-10-07
CRT PORTABLE EMERGENCY OXYGEN INHALATOR (K872170)Cost Reduction Technologies, Inc.1987-09-03
ACCU-FLO REGULATOR (K865077)Alum-Ox, Inc.1987-02-10
REGULATOR OXYGEN MECHANICAL (K863711)Lifeguard Medical Products, Inc.1987-01-27
AIRCO PRESSURE REGULATORS (K862796)Airco, Inc.1986-08-08
# 10099/10225/10235/10275/10525/10625/10715/10125 (K862193)U.O. Equipment Co.1986-07-09
PRESSURE REGULATOR (K853039)Erie Medical1986-04-11
OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER (K861166)Victor1986-04-01
DOWNS VPAP CIRCUIT (K852333)Vital Signs, Inc.1985-10-16
PORTABLE GASEOUS OXGYEN CONTAINER (K852663)Cryogenic Assoc.1985-08-29
PRESSURE REGULATOR/Y CONNECTOR (K852649)C.R. Bard, Inc.1985-08-02
OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18 (K852374)The Timeter Group1985-07-12
SAV-A-LIFE (K844622)Southern Medical Products, Inc.1985-02-26
AIRCO NITROUS OXIDE REGULATOR (K850106)Airco, Inc.1985-01-24
BEMCO PORTABLE OXYGEN INHALATOR (K843585)Bemco, Inc.1984-10-12
AIRCO OXYGEN REGULATOR (K841367)Welding Products1984-04-13
SLO-FLO 40AL ADJUST-FLOW REGULATOR (K834061)S.L.O. Health Products, Inc.1984-01-10
PORTABLE OXYGEN SYSTEM (K830844)Puritan Bennett Corp.1983-05-27
2002 ADJUSTABLE FLOW REGULATOR (K813467)Safety Laboratories West1982-01-07
4004 CONSTANT FLOW REGULATOR (K813466)Safety Laboratories West1982-01-07
ANESTHESIOLOGY DEVICE (K811430)Vital Air Oxygen Co.1981-06-09
MS-303-OXYGEN REGULATOR SHIELD (K810679)Instrumentation Industries, Inc.1981-04-17
MODEL 2 FLOWMETER (K810132)Harris Calorific1981-01-28
REGULATOR, OXYGEN MECHANICAL (K803207)Timeter Instrument Corp.1981-01-15
EMERG. OXYGEN KIT #65350 & #65399 CASE (K802644)B & F Medical Products, Inc.1980-12-22
O2 CONNECTOR (K780750)Diemolding Corp.1978-07-27
OXYGEN REGULATOR/FLOWMETER (K780359)Erie Mfg., Co.1978-04-04
MANIFOLD KIT (K780364)Spica, Inc.1978-03-30
OXYGEN THERAPY KIT (K780084)Thermadyne Holings Corp.1978-01-30
PORT-A-BOUT 240 (K772216)Hudson Oxygen Therapy Sales Co.1978-01-05
SPIR-E-VAC (K771241)Breathing Services, Inc.1977-09-15

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