Product code CBN— Anesthesiology
ISO-GARD MASK
- Classification name
- Apparatus, Gas-Scavenging
- Device class
- Class 2
- Regulation
- 21 CFR 868.5430
- Advisory panel
- Anesthesiology
- Total cleared
- 43
- First cleared
- Most recent
Market context for product code CBN
FDA has cleared devices under product code CBN between 1976 and 2023, filed by 34 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2020
- 2017
- 2014
- 2013
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 1998
- 1997
- 1996
Top applicants under product code CBN
Recent clearances under product code CBN
- K223452 — Nitronox Scavenger Plus
- K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2)
- K160950 — MINISCAV
- K142138 — ISO-GARD MASK
- K132729 — ISO-GARD MASK
- K123176 — ISO-GARD CLEARAIR MASK
- K110930 — ACTIVE WASTE GAS SCAVENGER
- K092031 — VAPOR-CLEAR, MODEL 100
- K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600
- K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT
- K063519 — DYNAMIC GAS SCAVENGING SYSTEM (DGSS)
- K033028 — ANEFIN, MODEL 100
- K033503 — RFS VACUUM GAUGE SCAVENGING CIRCUIT
- K981754 — AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
- K963601 — MODEL 1920 WASTE GAS SCAVENGER
- K965239 — PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)
- K953269 — SAFECIRCUIT MANIFOLD/PULMONARY UNIT
- K945216 — AES, (ANESCO EVACUATION SYSTEM) ACTIVE WASTE ANESTHETIC GAS EVACUATION SYSTEM
- K920043 — AIRES
- K915287 — ISOL-AIDE
- K921313 — AEROSTAR
- K904803 — CAP-EVAC ADAPTER
- K902161 — DEMISTIFIER ISOLATION CHAMBER
- K896510 — TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
- K893532 — RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
- K890438 — GAS-VAK(R), MODEL 300
- K884167 — TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.
- K864034 — OPEN RESERVOIR SCAVENGER
- K854571 — DEMAND FLOW VALVE & SONRA W/NASAL MASK
- K852772 — GAS EVACUATION ACCESSORY
- K841733 — OHIO WASTE GAS SCAVENGING RESERVOIR
- K841507 — FOSTER 757 SCAVENGER
- K842003 — OHIO WASTE GAS SCAVENGING INTERFACE
- K840849 — SCAVENGER TUBING 19MM
- K832752 — COMFORT CUSHION DISPOS. ANALGESIS
- K833692 — FRASER HARLAKE DENTAL ANTI-POLUTION SYS
- K821744 — FRASER HARLAKE NITRONOX SCAVENGER
- K802067 — CLEAN-AIR POLLUTION REDUCTION SYSTEM
- K791127 — POSIVAC
- K790333 — NAD SCAVENGING RELIEF VALVE
- K770344 — SH-1
- K761196 — NITROUS OXIDE SCAVENGING MASK
- K761140 — FRASER SWEATMAN'S DOUBLE MASK
Data sourced from openFDA. This site is unofficial and independent of the FDA.