Atlas FDA

CAD

57 FDA 510(k) clearances · Product code

86 daysmedian time to decision
302 days90th percentile
57clearances measured

FDA profile

Official device name
Vaporizer, Anesthesia, Non-Heated
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5880
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 12 · 2022: 13 · 2023: 44 · 2024: 255 · 2025: 2,714 · 2026: 490
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
V80 Anesthetic Vaporizer (V80) (K240375)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2024-10-31
Tec 820, Tec 850 (K172702)Datex-Ohmeda, Inc.2018-01-04
V60 Anesthetic Vaporizer (K150167)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015-06-30
SEVOFLURANE VAPORIZER ADAPTOR (K110608)Piramal Critcal Care, Inc (Formerly Minrad, Inc)2011-07-20
SIGMA ALPHA VAPORIZER (K060331)Penlon Limited2006-05-10
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (K053564)Penlon Limited2006-03-03
GAV - GENERAL ANAESTHETIC VAPORIZER (K051666)General Anaesthetic Services Limited2005-08-23
D-VAPOR (K042276)Draeger Medical, Inc.2004-09-23
DELTA T (K041076)Penlon , Ltd.2004-08-09
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (K031027)Datex-Ohmeda, Inc.2003-06-26
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (K012924)Datex-Ohmeda, Inc.2002-01-30
SIGMA DELTA (K002343)Penlon , Ltd.2001-06-08
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER (K002878)Datex-Ohmeda, Inc.2000-09-21
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA (K000275)Datex-Ohmeda, Inc.2000-04-12
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC (K990132)Datex-Ohmeda, Inc.1999-01-21
VAPAMASTA 6 (K980489)Medical Industrial Equipment1998-08-31
SIEMENS SEVOFLURANE VAPORIZER SV 953 (K980884)Siemens Medical Solutions USA, Inc.1998-08-19
DRAGER-VAPOR 19.3 (K981773)Draeger Medical, Inc.1998-07-06
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS (K981472)Draeger Medical, Inc.1998-05-07
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS (K973051)Draeger Medical, Inc.1997-10-30
DRAGER-VAPOR 2000 (K971923)Draeger Medical, Inc.1997-09-16
TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE (K952083)Clover Medical Equipment Services, Inc.1996-10-21
QUIK-FIL VAPORIZER KEYED FILLER (K961468)Penlon , Ltd.1996-07-16
PPV VAPORIZER (MODIFICATION) (K960944)Penlon , Ltd.1996-04-02
TECHNOFIL (K953748)Technimeca Medic, Inc.1996-01-25
TECHFIL (K954801)Technimeca Medic, Inc.1996-01-25
DATUM (K942799)Blease USA, Inc.1995-04-13
OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE (K942091)Ohmeda Medical1995-03-30
VAPOFIL (K945993)Southmedic, Inc.1995-02-22
SIGMA ELITE (K942545)Penlon , Ltd.1995-02-03
DRAGER-VAPOR 19.1 (K942055)North American Grager1995-01-27
SIGMA ELITE (K936046)Penlon, Inc.1994-11-04
FUNNEL ADAPTOR (K923265)Southmedic, Inc.1993-03-18
OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER (K913593)Ohmeda Medical1992-10-06
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER (K892057)Ohmeda Medical1989-04-26
VAPAMASTA 5 (K884686)Dentsply Intl.1989-03-15
LUNDY VAPORIZER SYSTEM (K884090)Vaporflow Technology, Inc.1989-01-24
VAPORIZER, ANESTHESIA, NON-HEATED (K882500)Anesthetic Vaporizer Services1988-08-01
KEYFILL (K872053)Mayfield Instruments, Ltd.1987-07-01
VAPLOK (K864605)Bear Medical Systems, Inc.1987-02-03
VAPOFIL (K861839)Southmedic, Inc.1986-05-21
VAPORIZER SPACER (K860545)Southmedic, Inc.1986-04-17
ANESTHESIA VENTILATOR MODEL 100 (K854202)Rusz Instruments, Inc.1986-04-11
PENLON PPV VAPORIZER (K844007)Penlon, Inc.1985-03-12
ANAESLOCK THREE VAPORIZER INTERLOCK HVA003 (K843993)Southmedic, Inc.1984-11-15
HALOTHANE VAPORIZER 950, ENFLURANE (K841157)Siemens Elema AB1984-06-07
CYPRANE TEC 4 CONTINUOUS FLOW VAPOR. (K831427)Fraser Harlake, Inc.1983-07-07
MODULUS VERNI-TROL ANESTHETIC VAPORIZER (K821966)Ohio Medical Products1982-07-16
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS (K821650)Draeger Medical, Inc.1982-06-29
MODULUS VERNI-TROL ANESTHETIC VAPORIZER (K810289)Ohio Medical Products1981-03-04
HALOTHANE VAPORIZER 950, & ENFLURANE 951 (K790359)Siemens Corp.1979-03-21
VALVE ANESTHETIC (K771892)Promed Corp.1978-02-02
VAPOR 19 (K771899)Draeger Medical, Inc.1977-10-18
COPPER KETTLE VAPORIZER PLUS (K771150)Air Products & Chemicals, Inc.1977-08-04
MASK, FACE, SURGICAL (K770021)Precept, Inc.1977-01-17
MODEL CNA-1 VAPORIZER (K761160)Cyprane North America, Inc.1976-12-09
SELECTATEC SYSTEM (K760668)Medishield, Inc.1976-09-27

Track CAD automatically

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