CBN · Class II · 21 CFR 868.5430

FDA Product Code CBN: Apparatus, Gas-scavenging

Leading manufacturers include Teleflexmedical, Inc., Ohio Medical Products and G. Dundas Co.,Inc..

43
Total
43
Cleared
142d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Apparatus, Gas-scavenging Devices (Product Code CBN)

43 devices
1–24 of 43
Cleared Mar 05, 2023
Nitronox Scavenger Plus
K223452
Parker Hannifin Corporation
Anesthesiology · 110d
Cleared Dec 04, 2020
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646
Anesthetic Gas Reclamation, Inc.
Anesthesiology · 340d
Cleared May 05, 2017
MINISCAV
K160950
Sedation Systems, LLC
Anesthesiology · 395d
Cleared Oct 30, 2014
ISO-GARD MASK
K142138
Teleflexmedical, Inc.
Anesthesiology · 86d
Cleared Jan 09, 2014
ISO-GARD MASK
K132729
Teleflexmedical, Inc.
Anesthesiology · 128d
Cleared Feb 14, 2013
ISO-GARD CLEARAIR MASK
K123176
Teleflexmedical, Inc.
Anesthesiology · 127d
Cleared Jun 23, 2011
ACTIVE WASTE GAS SCAVENGER
K110930
G. Dundas Co.,Inc.
Anesthesiology · 80d
Cleared Apr 16, 2010
VAPOR-CLEAR, MODEL 100
K092031
Axon Medical, Inc.
Anesthesiology · 284d
Cleared Apr 14, 2008
PASSIVE WASTE GAS SCAVENGER, MODEL 14600
K080039
G. Dundas Co.,Inc.
Anesthesiology · 98d
Cleared Oct 18, 2007
MINRAD INC. NASAL SCAVENGING CIRCUIT
K072255
Minrad, Inc.
Anesthesiology · 66d
Cleared Dec 01, 2006
DYNAMIC GAS SCAVENGING SYSTEM (DGSS)
K063519
Anesthetic Gas Reclamation, LLC
Anesthesiology · 10d
Cleared Jun 16, 1998
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
K981754
Porter Instrument Co., Inc.
Anesthesiology · 29d
Cleared Apr 28, 1997
MODEL 1920 WASTE GAS SCAVENGER
K963601
G. Dundas Co.
Anesthesiology · 231d
Cleared Mar 28, 1997
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)
K965239
Accutron, Inc.
Anesthesiology · 87d
Cleared Dec 20, 1996
SAFECIRCUIT MANIFOLD/PULMONARY UNIT
K953269
Advanced Warming Systems, Inc.
Anesthesiology · 526d
Cleared Aug 21, 1989
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532
Medipart Jerry Alexander
Anesthesiology · 105d
Cleared Dec 15, 1986
OPEN RESERVOIR SCAVENGER
K864034
Draeger Medical, Inc.
Anesthesiology · 61d
Cleared Oct 10, 1985
GAS EVACUATION ACCESSORY
K852772
Siemens Elema AB
Anesthesiology · 105d
Cleared Jul 11, 1984
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733
Ohio Medical Products
Anesthesiology · 76d
Cleared May 23, 1984
OHIO WASTE GAS SCAVENGING INTERFACE
K842003
Ohio Medical Products
Anesthesiology · 7d
Cleared Mar 12, 1984
SCAVENGER TUBING 19MM
K840849
The Kendal Co.
Anesthesiology · 17d
Cleared Jul 30, 1979
POSIVAC
K791127
Vital Signs, Inc.
Anesthesiology · 42d
Cleared Mar 22, 1979
NAD SCAVENGING RELIEF VALVE
K790333
Draeger Medical, Inc.
Anesthesiology · 34d
Cleared May 09, 1977
SH-1
K770344
Delta Medical Industries
Anesthesiology · 80d

About Product Code CBN - Regulatory Context

510(k) Submission Activity

43 total 510(k) submissions under product code CBN since 1976, with 43 receiving FDA clearance (average review time: 142 days).

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