CBN · Class II · 21 CFR 868.5430

FDA Product Code CBN: Apparatus, Gas-scavenging

Leading manufacturers include Teleflexmedical, Inc., Ohio Medical Products and Draeger Medical, 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 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 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

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.