Atlas FDA

BSZ

189 FDA 510(k) clearances · Product code

111 daysmedian time to decision
325 days90th percentile
189clearances measured

FDA profile

Official device name
Gas-Machine, Anesthesia
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5160
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 3,123 · 2022: 4,352 · 2023: 5,595 · 2024: 6,067 · 2025: 9,366 · 2026: 4,904
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
A5 Anesthesia System (A5); A7 Anesthesia System (A7) (K253330)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2026-06-25
Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) (K252746)Drägerwerk AG Co. Kgaa2026-05-21
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (K251352)Codonics.Incorporated2025-07-11
Atlan (K230931)Drägerwerk AG Co. Kgaa2023-07-23
Carestation 750/750c (K213867)Datex-Ohmeda, Inc.2023-03-28
A8, A9 Anesthesia System (K201957)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2021-03-26
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (K191027)Maquet Critical Care AB2020-03-18
A5 Anesthesia System (K171311)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-12
A7 Anesthesia System (K171292)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-12
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 (K172045)Datex-Ohmeda, Inc.2017-11-03
Aisys CS2 (K170872)Datex-Ohmeda, Inc.2017-08-15
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (K160665)Maquet Critical Care AB2017-03-29
Carestation 620/650/650C (K151570)Datex-Ohmeda, Inc.2016-01-21
A7 Anesthesia System (K151954)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-10-27
Aespire View (K143530)Datex-Ohmeda, Inc.2015-04-24
A7 Anesthesia System (K142552)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-01-23
MADM (K140264)Thornhill Research, Inc.2015-01-05
DRE VENTURA (K132903)Dre Medical, Inc.2014-07-01
PERSEUS A500 (K133886)Draeger Medical GmbH2014-06-20
A9800 ANESTHESIA WORKSTATION (K131790)Oricare, Inc.2014-05-09
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 (K133958)Maquet Critical Care AB2014-03-20
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) (K132530)Datex-Ohmeda, Inc.2013-12-20
GE DATEX-OHMEDA AVANCE CS2 (K131945)Datex-Ohmeda2013-08-08
INTELLISAVE AX700 ANESTHESIA SYSTEM (K122063)Philips Anesthesia Care2013-08-02
A5 ANESTHESIA DELIVERY SYSTEM (K123211)Datascope Corp., Patient Monitoring Division2013-02-14
GE DATEX-OHMEDA AVANCE CS2 (K123125)Datex-Ohmeda, Inc.2013-02-06
AESPIRE 7900, AESPIRE VIEW (K122445)Datex-Ohmeda2012-10-12
MCKESSON ANESTHESIA CARE (K113633)Mckesson Technologies, Inc.2012-04-20
SMARTPILOT VIEW MODEL MK04500 (K103035)Draeger Medical GmbH2012-03-28
AM-6000 ANESTHESIA MACHINE (K120075)Advanced Instrumentations, Inc.2012-01-26
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 (K112114)Maquet Critical Care AB2012-01-13
GE DATEX-OHMEDA AVANCE (K112722)Datex-Ohmeda, Inc.2011-12-16
GE DATEX-OHMEDA AISYS (K110213)Datex-Ohmeda, Inc.2011-07-20
NAVIGATOR APPLICATIONS SUITE (K102389)GE Healthcare Finland Oy2011-06-10
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 (K102182)Maquet Critical Care AB2011-05-09
AS3700 ANESTHSIA DELIVERY SYSTEM (K102471)Mindray DS USA, Inc.2011-02-11
CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P (K101439)Codonics, Inc.2011-02-07
AESPIRE 7900, AESPIRE VIEW (K092864)Datex-Ohmeda Inc., A Division of Instrumentarium C2010-01-12
GE DATEX-OHMEDA S/5 ADU CARESTATION (K090892)GE Healthcare Finland Oy2009-04-30
NAVIGATOR APPLICATIONS SUITE (K083098)GE Healthcare Finland Oy2009-04-01
GE DATEX-OHMEDA AISYS (K090233)Datex-Ohmeda, Inc.2009-03-05
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM (K083413)Philips Medical Systems2008-12-18
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO (K081447)Draeger Medical AG & Co. KG2008-10-08
GE DATEX-OHMEDA AVANCE (K081844)Datex-Ohmeda, Inc.2008-08-29
NAVIGATOR APPLICATIONS SUITE (K081941)GE Healthcare Finland Oy2008-08-07
FABIUS MRI (K072884)Draeger Medical AG & Co. KG2008-07-30
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 (K080175)Datascope Corp., Patient Monitoring Division2008-06-09
GE DATEX-OHMEDA AISYS (K073707)Datex-Ohmeda, Inc.2008-01-30
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE (K072420)Oceanic Medical Products, Inc.2008-01-22
NAVIGATOR APPLICATIONS SUITE (K071097)GE Healthcare Finland Oy2007-10-10
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM (K071142)Datex-Ohmeda2007-06-06
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM (K062388)Docusys2007-02-22
DIGITAL MXR-D FLOWMETER (K062155)Porter Instrument Co., Inc.2006-11-09
PRIMA ANAESTHESIA MACHINE (K061102)Penlon , Ltd.2006-07-28
GE DATEX-OHMEDA AISYS (K061609)Datex-Ohmeda, Inc.2006-06-27
MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 (K060193)Oceanic Medical Products, Inc.2006-04-10
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA (K052335)Accutron, Inc.2005-11-23
SAFERSLEEP SYSTEM (K050883)Safer Sleep, LLC2005-11-04
BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 (K051629)Blease USA, Inc.2005-09-23
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) (K050676)Datex-Ohmeda, Inc.2005-04-12
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM (K050626)Datex-Ohmeda, Inc.2005-03-25
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM (K050055)Datex-Ohmeda, Inc.2005-02-04
PRIMUS US (K042607)Draeger Medical, Inc.2004-11-26
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM (K042419)Draeger Medical, Inc.2004-10-08
BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 (K041430)Blease Medical Equipment , Ltd.2004-10-07
MALLARD MODEL 3000 ANESTHESIA MACHINE (K033026)Mallard Medical, Inc.2004-09-03
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (K042086)Draeger Medical, Inc.2004-08-31
GE DATEX-OHMEDA AISYS CARESTATION (K042154)Datex-Ohmeda, Inc.2004-08-31
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM (K041622)Draeger Medical, Inc.2004-07-08
NARKOMED 6400, MODEL NM6400 (K033498)Draeger Medical, Inc.2004-04-26
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM (K040743)Datex-Ohmeda, Inc.2004-04-22
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM (K030624)Draeger Medical, Inc.2004-03-17
DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM (K032803)Datex-Ohmeda2004-03-10
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE (K030939)Philips Medical Systems2003-07-15
FABIUS TIRO ANESTHESIA SYSTEM (K031400)Draeger Medical, Inc.2003-07-15
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 (K022031)Draeger Medical, Inc.2002-08-29
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS (K011404)Draeger Medical, Inc.2002-02-22
MAGELLAN-2200, MODEL 1 (K010613)Oceanic Medical Products, Inc.2001-10-12
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI (K012446)Charles A. Smith2001-10-03
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE (K003663)Spacelabs Medical, Inc.2001-06-28
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 (K003251)Blease Medical Equipment , Ltd.2001-05-23
MODULAR (K001988)Heyer America, Inc.2001-02-05
NARKOMED MRI-2, MODEL NM-MRI-2 (K003579)Draeger Medical, Inc.2001-01-22
NARKOMAT, MODEL 2000 (K000995)Heyer America, Inc.2000-10-11
OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 (K000859)Charles A. Smith2000-08-23
MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES (K001727)Blease Medical Equipment , Ltd.2000-08-09
NARKOMED MRI , NM-MRI (K001488)Draeger Medical, Inc.2000-06-09
MODIFICATION TO KION ANESTHESIA SYSTEM (K001315)Siemens Elema AB2000-05-26
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR (K000706)Datex-Ohmeda, Inc.2000-05-11
DATES-OHMEDA AESTIVA SMARTVENT MRI (K993410)Datex-Ohmeda, Inc.2000-04-25
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 (K992421)Accutron, Inc.1999-10-27
KION ANESTHESIA SYSTEM (K973971)Siemens Medical Solutions USA, Inc.1999-09-13
BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE (K982137)Blease Medical Equipment , Ltd.1999-04-09
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN (K983635)Draeger Medical, Inc.1999-01-11
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM (K981530)Spacelabs Medical, Inc.1998-11-20
HAWK ANAESTHESIA INDUCTION UNIT (K981845)Medical Industrial Equipment1998-11-03
AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) (K973985)Datex-Engstrom, Inc.1998-10-30
NARKOMED 6000 MODEL NUMBER NM6000 (K980553)Draeger Medical, Inc.1998-08-04
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM (K973896)Ohmeda Medical1998-04-21
PERIOPERATIVE DATA MANAGEMENT SYSTEM (K973949)Draeger Medical, Inc.1998-02-06
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