Atlas FDA

BYJ

55 FDA 510(k) clearances · Product code

52 daysmedian time to decision
179 days90th percentile
55clearances measured

FDA profile

Official device name
Unit, Liquid-Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5655
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 34 · 2016: 19 · 2017: 18 · 2018: 21 · 2019: 24 · 2020: 39
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
DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (K130068)Essex Industries, Inc. D/B/A Essex Cryogenics of M2013-07-19
MOUNTED MEDICAL OXYGEN SYSTEM (K113767)Essex Industries, Inc.2012-06-29
PRECISION LIQUID OXYGEN SYSTEM (K103324)Precision Medical, Inc.2011-04-21
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (K101272)Essex Industries, Inc.2010-08-20
GOLOX-93 (K081779)Respironics, Inc.2008-09-19
MODIFICATION TO: SPIRIT (K080023)Caire, Inc.2008-06-16
RESPIRONICS GOLOX (K072723)Respironics, Inc.2008-03-20
COPD LIQUID OXYGEN PORTABLE, MODEL 300P (K072011)Copd Partners, Inc.2007-10-18
BACKPACK MEDICAL OXYGEN SYSTEM (K071581)Essex Cryogenics of Missouri, Inc.2007-07-11
SPIRIT, MODEL HAS (K050153)Caire, Inc.2005-04-15
PLIX (K050414)Respironics, Inc.2005-04-11
PRECISION LIQUID OXYGEN SYSTEM (K041122)Precision Medical, Inc.2004-10-04
LIQUID OXYGEN SYSTEM (K032143)Micro Technology Services, Inc.2004-03-30
NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM (K033000)Essex Cryogenics of Missouri, Inc.2004-03-22
SPIRIT 300 (K013251)Caire, Inc.2001-12-18
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM (K993220)Puritan Bennett Corp.1999-10-22
PROTEGE LIQUID OXYGEN SYSTEM (K971545)Healthdyne Technologies, Inc.1997-07-25
PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT (K963956)Southern Research, Inc.1996-12-09
LIQUID OXYGEN STORAGE SUBSYSTEM (K941819)Hogan & Hartson1994-05-23
PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT (K933930)Puritan Bennett Corp.1994-03-21
MOBILAIRE LIQUID OXYGEN SYSTEMS (K926267)Invacare Corp.1993-08-31
PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE (K903140)Puritan Bennett Corp.1990-09-05
PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN (K895387)Puritan Bennett Corp.1990-01-24
VOYAGER PX (K895082)Smith-Perry Corp.1990-01-09
HI FLOW 50 (K882328)Minnesota Valley Engineering, Inc.1988-06-28
PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT (K880183)Essex Cryogenics of Missouri, Inc.1988-04-14
LIBERATOR 53/STROLLER 50 (K880101)Minnesota Valley Engineering, Inc.1988-02-29
HI FLOW PORTABLE LIQUID OXYGEN UNIT (K875352)Minnesota Valley Engineering, Inc.1988-02-29
NOMAD (BASE UNIT/PORTABLE UNIT) (K872449)Minnesota Valley Engineering, Inc.1987-07-21
ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT (K864280)Smith-Taylor Mfg. Co., Div. Allied Medical Corp.1987-01-28
PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) (K863978)Penox Technologies, Inc.1986-12-15
CSI LIQUID OXYGEN SYSTEM (K863556)Cryogenic Services, Inc.1986-10-15
SWIVEL COUPLER (K863205)Venmill Swivel, Co.1986-10-02
CTC 30, 40, 1 LIQUID OXYGEN LITERS (K860738)Cryodyne Technologies, Inc.1986-08-06
COMPANION LIQUID OXYGEN SYSTEM (K861503)Puritan Bennett Corp.1986-06-25
MARK 4 LIQUID OXYGEN SYSTEM (K860937)Puritan Bennett Corp.1986-03-20
PENOX HIGH FLOW MANIFOLD (K853775)Penox Technologies, Inc.1985-11-29
RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR (K853083)Home Medical Supply, Inc.1985-09-03
STROLLER SPRINT (K841808)Cryogenic Assoc.1984-05-16
LIQUID OXYGEN SYSTEM (K840534)The John Bunn Co.1984-03-02
INSPIRON LIQUID OXYGEN SYSTEM (K834290)Inspiron Corp.1984-02-04
PULSAIR I & II (K833994)Cryo Corp.1983-12-12
MARK III OXYGEN WALKER SYS. RESERVOIR (K832143)Linde Div. Union Carbide Corp.1983-08-26
MARK III OXYGEN WALKER SYS-LOW PRESS (K830337)Union Carbide Corp.1983-03-17
LIQUID OXYGEN SYSTEM (K830498)Puritan Bennett Corp.1983-03-10
MARK III OXYGEN WALKER SYSTEM (K820836)Union Carbide Corp.1982-04-15
UNIT, LIQUID, OXYGEN, PORTABLE (K813453)Pensee Medical Corp.1982-01-12
LINDE MARK II (K812536)Union Carbide Corp.1981-09-23
FLOWLOCK OXYGEN METER (K811162)Lifeguard Medical Products, Inc.1981-05-08
LINDE MARK II OXYGEN RESERV. TYPE OR-4 (K810732)Union Carbide Corp.1981-03-27
LIBERATOR/STROLLER II SYSTEM (K800742)Cryogenic Assoc.1980-05-23
LINDE OXYGEN WALKER SYS. MARK II-L (K791902)Union Carbide Corp.1979-10-17
TRAVELAIR AND STATIONAIR (K780496)Cryomed Corp.1978-04-18
LIQUID OXYGEN UNIT, PORTABLE 73BYJ (K780098)Andonian Cryogenics, Inc.1978-03-02
LIBERATOR/STROLLER (K760787)Burditt & Calkins-Siemens-Elema1976-10-22

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