CBN · Apparatus, Gas-Scavenging
Anesthesiology · 21 CFR 868.5430 · Class 2
Overview
| Product Code | CBN |
|---|---|
| Device Name | Apparatus, Gas-Scavenging |
| Regulation | 21 CFR 868.5430 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223452 | Nitronox Scavenger Plus | Parker Hannifin Corporation | Mar 5, 2023 | SESE |
| K193646 | Dynamic Gas Scavenging System 2 (DGSS - 2) | Anesthetic Gas Reclamation, Inc. | Dec 4, 2020 | SESE |
| K160950 | MINISCAV | Sedation Systems, LLC | May 5, 2017 | SESE |
| K142138 | ISO-GARD MASK | Teleflexmedical, Inc. | Oct 30, 2014 | SESE |
| K132729 | ISO-GARD MASK | Teleflexmedical, Inc. | Jan 9, 2014 | SESE |
| K123176 | ISO-GARD CLEARAIR MASK | Teleflexmedical, Inc. | Feb 14, 2013 | SESE |
| K110930 | ACTIVE WASTE GAS SCAVENGER | G. Dundas Co.,Inc. | Jun 23, 2011 | SESE |
| K092031 | VAPOR-CLEAR, MODEL 100 | Axon Medical, Inc. | Apr 16, 2010 | SESE |
| K080039 | PASSIVE WASTE GAS SCAVENGER, MODEL 14600 | G. Dundas Co.,Inc. | Apr 14, 2008 | SESE |
| K072255 | MINRAD INC. NASAL SCAVENGING CIRCUIT | Minrad, Inc. | Oct 18, 2007 | SESE |
| K063519 | DYNAMIC GAS SCAVENGING SYSTEM (DGSS) | Anesthetic Gas Reclamation, LLC | Dec 1, 2006 | SESE |
| K033028 | ANEFIN, MODEL 100 | Axon Medical | Jul 22, 2005 | SESE |
| K033503 | RFS VACUUM GAUGE SCAVENGING CIRCUIT | Accutron, Inc. | Mar 12, 2004 | SESE |
| K981754 | AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 | Porter Instrument Co., Inc. | Jun 16, 1998 | SESE |
| K963601 | MODEL 1920 WASTE GAS SCAVENGER | G. Dundas Co. | Apr 28, 1997 | SESE |
| K965239 | PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) | Accutron, Inc. | Mar 28, 1997 | SESE |
| K953269 | SAFECIRCUIT MANIFOLD/PULMONARY UNIT | Advanced Warming Systems, Inc. | Dec 20, 1996 | SESE |
| K945216 | AES, (ANESCO EVACUATION SYSTEM) ACTIVE WASTE ANESTHETIC GAS EVACUATION SYSTEM | Anesco | Sep 15, 1995 | SESE |
| K920043 | AIRES | Viva-Tek Assoc., Inc. | Jun 16, 1993 | SESE |
| K915287 | ISOL-AIDE | Computronic Systems | Oct 16, 1992 | SESE |
Top Applicants
- Teleflexmedical, Inc. — 3 clearances
- Accutron, Inc. — 2 clearances
- Draeger Medical, Inc. — 2 clearances
- Fraser Harlake, Inc. — 2 clearances
- G. Dundas Co.,Inc. — 2 clearances
