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 Ohmeda Medical.

57
Total
57
Cleared
119d
Avg days
1976
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 267d recently vs 116d historically

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 Sep 23, 2004
D-VAPOR
K042276
Draeger Medical, Inc.
Anesthesiology · 31d
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 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 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 Mar 30, 1995
OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
K942091
Ohmeda Medical
Anesthesiology · 332d
Cleared Oct 06, 1992
OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
K913593
Ohmeda Medical
Anesthesiology · 420d
Cleared Apr 26, 1989
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057
Ohmeda Medical
Anesthesiology · 28d
Cleared Mar 15, 1989
VAPAMASTA 5
K884686
Dentsply Intl.
Anesthesiology · 127d
Cleared Jun 07, 1984
HALOTHANE VAPORIZER 950, ENFLURANE
K841157
Siemens Elema AB
Anesthesiology · 80d
Cleared Jul 16, 1982
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K821966
Ohio Medical Products
Anesthesiology · 14d
Cleared Jun 29, 1982
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650
Draeger Medical, Inc.
Anesthesiology · 25d
Cleared Mar 04, 1981
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K810289
Ohio Medical Products
Anesthesiology · 30d
Cleared Mar 21, 1979
HALOTHANE VAPORIZER 950, & ENFLURANE 951
K790359
Siemens Corp.
Anesthesiology · 27d
Cleared Oct 18, 1977
VAPOR 19
K771899
Draeger Medical, Inc.
Anesthesiology · 12d

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 increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - CAD Product Code

Recent submissions under CAD have taken an average of 267 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.

CAD devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →