FDA Product Code
FDA Product Code BSZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5160
510(k) Clearances — 189 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-06-25 | Traditional | PDF ↗ |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | 2026-05-21 | Traditional | PDF ↗ |
| K251352 | 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) | Codonics.Incorporated | 2025-07-11 | Traditional | PDF ↗ |
| K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023-07-23 | Traditional | PDF ↗ |
| K213867 | Carestation 750/750c | Datex-Ohmeda, Inc. | 2023-03-28 | Traditional | PDF ↗ |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 | Traditional | PDF ↗ |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Maquet Critical Care AB | 2020-03-18 | Traditional | PDF ↗ |
| K171292 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 | Traditional | PDF ↗ |
| K171311 | A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-01-12 | Traditional | PDF ↗ |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 | Datex-Ohmeda, Inc. | 2017-11-03 | Traditional | PDF ↗ |
| K170872 | Aisys CS2 | Datex-Ohmeda, Inc. | 2017-08-15 | Traditional | PDF ↗ |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Maquet Critical Care AB | 2017-03-29 | Abbreviated | PDF ↗ |
| K151570 | Carestation 620/650/650C | Datex-Ohmeda, Inc. | 2016-01-21 | Traditional | PDF ↗ |
| K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-10-27 | Traditional | PDF ↗ |
| K143530 | Aespire View | Datex-Ohmeda, Inc. | 2015-04-24 | Traditional | PDF ↗ |
| K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-01-23 | Traditional | PDF ↗ |
| K140264 | MADM | Thornhill Research, Inc. | 2015-01-05 | Traditional | PDF ↗ |
| K132903 | DRE VENTURA | Dre Medical, Inc. | 2014-07-01 | Traditional | PDF ↗ |
| K133886 | PERSEUS A500 | Draeger Medical GmbH | 2014-06-20 | Traditional | PDF ↗ |
| K131790 | A9800 ANESTHESIA WORKSTATION | Oricare, Inc. | 2014-05-09 | Traditional | PDF ↗ |
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Maquet Critical Care AB | 2014-03-20 | Abbreviated | PDF ↗ |
| K132530 | GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) | Datex-Ohmeda, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K131945 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda | 2013-08-08 | Special | PDF ↗ |
| K122063 | INTELLISAVE AX700 ANESTHESIA SYSTEM | Philips Anesthesia Care | 2013-08-02 | Traditional | PDF ↗ |
| K123211 | A5 ANESTHESIA DELIVERY SYSTEM | Datascope Corp., Patient Monitoring Division | 2013-02-14 | Abbreviated | PDF ↗ |
| K123125 | GE DATEX-OHMEDA AVANCE CS2 | Datex-Ohmeda, Inc. | 2013-02-06 | Special | PDF ↗ |
| K122445 | AESPIRE 7900, AESPIRE VIEW | Datex-Ohmeda | 2012-10-12 | Special | PDF ↗ |
| K113633 | MCKESSON ANESTHESIA CARE | Mckesson Technologies, Inc. | 2012-04-20 | Traditional | PDF ↗ |
| K103035 | SMARTPILOT VIEW MODEL MK04500 | Draeger Medical GmbH | 2012-03-28 | Traditional | PDF ↗ |
| K120075 | AM-6000 ANESTHESIA MACHINE | Advanced Instrumentations, Inc. | 2012-01-26 | Traditional | PDF ↗ |
| K112114 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 | Maquet Critical Care AB | 2012-01-13 | Traditional | PDF ↗ |
| K112722 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K110213 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2011-07-20 | Traditional | PDF ↗ |
| K102389 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2011-06-10 | Special | PDF ↗ |
| K102182 | MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 | Maquet Critical Care AB | 2011-05-09 | Abbreviated | PDF ↗ |
| K102471 | AS3700 ANESTHSIA DELIVERY SYSTEM | Mindray DS USA, Inc. | 2011-02-11 | Abbreviated | PDF ↗ |
| K101439 | CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P | Codonics, Inc. | 2011-02-07 | Traditional | PDF ↗ |
| K092864 | AESPIRE 7900, AESPIRE VIEW | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010-01-12 | Special | PDF ↗ |
| K090892 | GE DATEX-OHMEDA S/5 ADU CARESTATION | GE Healthcare Finland Oy | 2009-04-30 | Special | PDF ↗ |
| K083098 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2009-04-01 | Traditional | PDF ↗ |
| K090233 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2009-03-05 | Special | PDF ↗ |
| K083413 | COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM | Philips Medical Systems | 2008-12-18 | Special | PDF ↗ |
| K081447 | FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO | Draeger Medical AG & Co. KG | 2008-10-08 | Traditional | PDF ↗ |
| K081844 | GE DATEX-OHMEDA AVANCE | Datex-Ohmeda, Inc. | 2008-08-29 | Special | PDF ↗ |
| K081941 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2008-08-07 | Special | PDF ↗ |
| K072884 | FABIUS MRI | Draeger Medical AG & Co. KG | 2008-07-30 | Traditional | PDF ↗ |
| K080175 | NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01 | Datascope Corp., Patient Monitoring Division | 2008-06-09 | Abbreviated | PDF ↗ |
| K073707 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2008-01-30 | Special | PDF ↗ |
| K072420 | MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE | Oceanic Medical Products, Inc. | 2008-01-22 | Special | PDF ↗ |
| K071097 | NAVIGATOR APPLICATIONS SUITE | GE Healthcare Finland Oy | 2007-10-10 | Traditional | PDF ↗ |
| K071142 | GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM | Datex-Ohmeda | 2007-06-06 | Special | PDF ↗ |
| K062388 | ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM | Docusys | 2007-02-22 | Traditional | PDF ↗ |
| K062155 | DIGITAL MXR-D FLOWMETER | Porter Instrument Co., Inc. | 2006-11-09 | Traditional | PDF ↗ |
| K061102 | PRIMA ANAESTHESIA MACHINE | Penlon , Ltd. | 2006-07-28 | Special | PDF ↗ |
| K061609 | GE DATEX-OHMEDA AISYS | Datex-Ohmeda, Inc. | 2006-06-27 | Special | PDF ↗ |
| K060193 | MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 | Oceanic Medical Products, Inc. | 2006-04-10 | Traditional | PDF ↗ |
| K052335 | ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA | Accutron, Inc. | 2005-11-23 | Traditional | PDF ↗ |
| K050883 | SAFERSLEEP SYSTEM | Safer Sleep, LLC | 2005-11-04 | Traditional | PDF ↗ |
| K051629 | BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 | Blease USA, Inc. | 2005-09-23 | Special | PDF ↗ |
| K050676 | GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) | Datex-Ohmeda, Inc. | 2005-04-12 | Special | PDF ↗ |
| K050626 | GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | 2005-03-25 | Special | PDF ↗ |
| K050055 | GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | 2005-02-04 | Special | PDF ↗ |
| K042607 | PRIMUS US | Draeger Medical, Inc. | 2004-11-26 | Traditional | PDF ↗ |
| K042419 | FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | 2004-10-08 | Traditional | PDF ↗ |
| K041430 | BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 | Blease Medical Equipment , Ltd. | 2004-10-07 | Special | PDF ↗ |
| K033026 | MALLARD MODEL 3000 ANESTHESIA MACHINE | Mallard Medical, Inc. | 2004-09-03 | Traditional | PDF ↗ |
| K042154 | GE DATEX-OHMEDA AISYS CARESTATION | Datex-Ohmeda, Inc. | 2004-08-31 | Special | PDF ↗ |
| K042086 | FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | 2004-08-31 | Traditional | PDF ↗ |
| K041622 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | 2004-07-08 | Special | PDF ↗ |
| K033498 | NARKOMED 6400, MODEL NM6400 | Draeger Medical, Inc. | 2004-04-26 | Traditional | PDF ↗ |
| K040743 | MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM | Datex-Ohmeda, Inc. | 2004-04-22 | Special | PDF ↗ |
| K030624 | MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM | Draeger Medical, Inc. | 2004-03-17 | Traditional | PDF ↗ |
| K032803 | DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM | Datex-Ohmeda | 2004-03-10 | Traditional | PDF ↗ |
| K030939 | PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE | Philips Medical Systems | 2003-07-15 | Special | PDF ↗ |
| K031400 | FABIUS TIRO ANESTHESIA SYSTEM | Draeger Medical, Inc. | 2003-07-15 | Special | PDF ↗ |
| K022031 | NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2 | Draeger Medical, Inc. | 2002-08-29 | Traditional | PDF ↗ |
| K011404 | FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS | Draeger Medical, Inc. | 2002-02-22 | Traditional | PDF ↗ |
| K010613 | MAGELLAN-2200, MODEL 1 | Oceanic Medical Products, Inc. | 2001-10-12 | Traditional | PDF ↗ |
| K012446 | OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI | Charles A. Smith | 2001-10-03 | Special | PDF ↗ |
| K003663 | SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE | Spacelabs Medical, Inc. | 2001-06-28 | Traditional | PDF ↗ |
| K003251 | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 | Blease Medical Equipment , Ltd. | 2001-05-23 | Traditional | PDF ↗ |
| K001988 | MODULAR | Heyer America, Inc. | 2001-02-05 | Traditional | PDF ↗ |
| K003579 | NARKOMED MRI-2, MODEL NM-MRI-2 | Draeger Medical, Inc. | 2001-01-22 | Special | PDF ↗ |
| K000995 | NARKOMAT, MODEL 2000 | Heyer America, Inc. | 2000-10-11 | Traditional | PDF ↗ |
| K000859 | OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 | Charles A. Smith | 2000-08-23 | Traditional | PDF ↗ |
| K001727 | MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES | Blease Medical Equipment , Ltd. | 2000-08-09 | Special | PDF ↗ |
| K001488 | NARKOMED MRI , NM-MRI | Draeger Medical, Inc. | 2000-06-09 | Special | PDF ↗ |
| K001315 | MODIFICATION TO KION ANESTHESIA SYSTEM | Siemens Elema AB | 2000-05-26 | Special | PDF ↗ |
| K000706 | DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR | Datex-Ohmeda, Inc. | 2000-05-11 | Special | PDF ↗ |
| K993410 | DATES-OHMEDA AESTIVA SMARTVENT MRI | Datex-Ohmeda, Inc. | 2000-04-25 | Traditional | PDF ↗ |
| K992421 | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 | Accutron, Inc. | 1999-10-27 | Special | PDF ↗ |
| K973971 | KION ANESTHESIA SYSTEM | Siemens Medical Solutions USA, Inc. | 1999-09-13 | Traditional | PDF ↗ |
| K982137 | BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE | Blease Medical Equipment , Ltd. | 1999-04-09 | Traditional | PDF ↗ |
| K983635 | JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN | Draeger Medical, Inc. | 1999-01-11 | Traditional | PDF ↗ |
| K981530 | SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM | Spacelabs Medical, Inc. | 1998-11-20 | Traditional | PDF ↗ |
| K981845 | HAWK ANAESTHESIA INDUCTION UNIT | Medical Industrial Equipment | 1998-11-03 | Traditional | PDF ↗ |
| K973985 | AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU) | Datex-Engstrom, Inc. | 1998-10-30 | Traditional | PDF ↗ |
| K980553 | NARKOMED 6000 MODEL NUMBER NM6000 | Draeger Medical, Inc. | 1998-08-04 | Traditional | PDF ↗ |
| K973896 | OHMEDA EXCEL 3000 ANESTHESIA SYSTEM | Ohmeda Medical | 1998-04-21 | Traditional | PDF ↗ |
| K973949 | PERIOPERATIVE DATA MANAGEMENT SYSTEM | Draeger Medical, Inc. | 1998-02-06 | Traditional | PDF ↗ |
Product code BSZ · Class II · Anesthesiology. Data: openFDA.