CAD · Class II · 21 CFR 868.5880

FDA Product Code CAD: Vaporizer, Anesthesia, Non-heated

Leading manufacturers include Draeger Medical, Inc., Datex-Ohmeda, Inc. and Southmedic, Inc..

57
Total
57
Cleared
119d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Vaporizer, Anesthesia, Non-heated Devices (Product Code CAD)

57 devices
1–24 of 57
Cleared Oct 31, 2024
V80 Anesthetic Vaporizer (V80)
K240375
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 267d
Cleared Jan 04, 2018
Tec 820, Tec 850
K172702
Datex-Ohmeda, Inc.
Anesthesiology · 119d
Cleared Jun 30, 2015
V60 Anesthetic Vaporizer
K150167
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Anesthesiology · 155d
Cleared Jul 20, 2011
SEVOFLURANE VAPORIZER ADAPTOR
K110608
Piramal Critcal Care, Inc (Formerly Minrad, Inc)
Anesthesiology · 139d
Cleared May 10, 2006
SIGMA ALPHA VAPORIZER
K060331
Penlon Limited
Anesthesiology · 90d
Cleared Mar 03, 2006
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
K053564
Penlon Limited
Anesthesiology · 71d
Cleared Aug 23, 2005
GAV - GENERAL ANAESTHETIC VAPORIZER
K051666
General Anaesthetic Services Limited
Anesthesiology · 62d
Cleared Sep 23, 2004
D-VAPOR
K042276
Draeger Medical, Inc.
Anesthesiology · 31d
Cleared Aug 09, 2004
DELTA T
K041076
Penlon , Ltd.
Anesthesiology · 105d
Cleared Jun 26, 2003
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
K031027
Datex-Ohmeda, Inc.
Anesthesiology · 86d
Cleared Jan 30, 2002
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924
Datex-Ohmeda, Inc.
Anesthesiology · 152d
Cleared Jun 08, 2001
SIGMA DELTA
K002343
Penlon , Ltd.
Anesthesiology · 311d
Cleared Sep 21, 2000
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
K002878
Datex-Ohmeda, Inc.
Anesthesiology · 6d
Cleared Apr 12, 2000
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
K000275
Datex-Ohmeda, Inc.
Anesthesiology · 72d
Cleared Jan 21, 1999
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
K990132
Datex-Ohmeda, Inc.
Anesthesiology · 7d
Cleared Aug 31, 1998
VAPAMASTA 6
K980489
Medical Industrial Equipment
Anesthesiology · 203d
Cleared Aug 19, 1998
SIEMENS SEVOFLURANE VAPORIZER SV 953
K980884
Siemens Medical Solutions USA, Inc.
Anesthesiology · 163d
Cleared Jul 06, 1998
DRAGER-VAPOR 19.3
K981773
Draeger Medical, Inc.
Anesthesiology · 47d
Cleared May 07, 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472
Draeger Medical, Inc.
Anesthesiology · 13d
Cleared Oct 30, 1997
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K973051
Draeger Medical, Inc.
Anesthesiology · 76d
Cleared Sep 16, 1997
DRAGER-VAPOR 2000
K971923
Draeger Medical, Inc.
Anesthesiology · 116d
Cleared Oct 21, 1996
TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
K952083
Clover Medical Equipment Services, Inc.
Anesthesiology · 537d
Cleared Jul 16, 1996
QUIK-FIL VAPORIZER KEYED FILLER
K961468
Penlon , Ltd.
Anesthesiology · 90d
Cleared Apr 02, 1996
PPV VAPORIZER (MODIFICATION)
K960944
Penlon , Ltd.
Anesthesiology · 49d

About Product Code CAD - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code CAD since 1976, with 57 receiving FDA clearance (average review time: 119 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.