Atlas FDA

CBN

43 FDA 510(k) clearances · Product code

87 daysmedian time to decision
340 days90th percentile
43clearances measured

FDA profile

Official device name
Apparatus, Gas-Scavenging
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5430
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Nitronox Scavenger Plus (K223452)Parker Hannifin Corporation2023-03-05
Dynamic Gas Scavenging System 2 (DGSS - 2) (K193646)Anesthetic Gas Reclamation, Inc.2020-12-04
MINISCAV (K160950)Sedation Systems, LLC2017-05-05
ISO-GARD MASK (K142138)Teleflexmedical, Inc.2014-10-30
ISO-GARD MASK (K132729)Teleflexmedical, Inc.2014-01-09
ISO-GARD CLEARAIR MASK (K123176)Teleflexmedical, Inc.2013-02-14
ACTIVE WASTE GAS SCAVENGER (K110930)G. Dundas Co.,Inc.2011-06-23
VAPOR-CLEAR, MODEL 100 (K092031)Axon Medical, Inc.2010-04-16
PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (K080039)G. Dundas Co.,Inc.2008-04-14
MINRAD INC. NASAL SCAVENGING CIRCUIT (K072255)Minrad, Inc.2007-10-18
DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (K063519)Anesthetic Gas Reclamation, LLC2006-12-01
ANEFIN, MODEL 100 (K033028)Axon Medical2005-07-22
RFS VACUUM GAUGE SCAVENGING CIRCUIT (K033503)Accutron, Inc.2004-03-12
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 (K981754)Porter Instrument Co., Inc.1998-06-16
MODEL 1920 WASTE GAS SCAVENGER (K963601)G. Dundas Co.1997-04-28
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) (K965239)Accutron, Inc.1997-03-28
SAFECIRCUIT MANIFOLD/PULMONARY UNIT (K953269)Advanced Warming Systems, Inc.1996-12-20
AES, (ANESCO EVACUATION SYSTEM) ACTIVE WASTE ANESTHETIC GAS EVACUATION SYSTEM (K945216)Anesco1995-09-15
AIRES (K920043)Viva-Tek Assoc., Inc.1993-06-16
ISOL-AIDE (K915287)Computronic Systems1992-10-16
AEROSTAR (K921313)Biosafety Systems, Inc.1992-09-11
CAP-EVAC ADAPTER (K904803)Logan, Inc.1990-11-05
DEMISTIFIER ISOLATION CHAMBER (K902161)Peace Medical, Inc.1990-10-15
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. (K896510)Technical Medical Products, Inc.1990-01-22
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963 (K893532)Medipart Jerry Alexander1989-08-21
GAS-VAK(R), MODEL 300 (K890438)Gas-Vak1989-08-07
TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. (K884167)Technical Medical Products, Inc.1988-10-28
OPEN RESERVOIR SCAVENGER (K864034)Draeger Medical, Inc.1986-12-15
DEMAND FLOW VALVE & SONRA W/NASAL MASK (K854571)Gale E. Dryden1986-02-10
GAS EVACUATION ACCESSORY (K852772)Siemens Elema AB1985-10-10
OHIO WASTE GAS SCAVENGING RESERVOIR (K841733)Ohio Medical Products1984-07-11
FOSTER 757 SCAVENGER (K841507)Colson Equipment, Inc.1984-06-14
OHIO WASTE GAS SCAVENGING INTERFACE (K842003)Ohio Medical Products1984-05-23
SCAVENGER TUBING 19MM (K840849)The Kendal Co.1984-03-12
COMFORT CUSHION DISPOS. ANALGESIS (K832752)Mission Dental, Inc.1983-12-08
FRASER HARLAKE DENTAL ANTI-POLUTION SYS (K833692)Fraser Harlake, Inc.1983-11-29
FRASER HARLAKE NITRONOX SCAVENGER (K821744)Fraser Harlake, Inc.1982-06-25
CLEAN-AIR POLLUTION REDUCTION SYSTEM (K802067)Porter Instrument Co., Inc.1980-09-26
POSIVAC (K791127)Vital Signs, Inc.1979-07-30
NAD SCAVENGING RELIEF VALVE (K790333)Draeger Medical, Inc.1979-03-22
SH-1 (K770344)Delta Medical Industries1977-05-09
NITROUS OXIDE SCAVENGING MASK (K761196)Mckesson Corp.1976-12-13
FRASER SWEATMAN'S DOUBLE MASK (K761140)Fraser Sweatman, Inc.1976-12-09

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Every clearance here is in the API, with alerts when new ones post.