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510(k) K092031

VAPOR-CLEAR, MODEL 100 by Axon Medical, Inc. — Product Code CBN

K092031 is an FDA 510(k) premarket notification submitted by Axon Medical, Inc. for the device "VAPOR-CLEAR, MODEL 100". The FDA issued a decision of Substantially Equivalent on April 16, 2010. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Axon Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2010
Date Received
July 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

Other clearances by Axon Medical, Inc.

  • K033028 — ANEFIN, MODEL 100 (July 22, 2005)

Other clearances for product code CBN

  • K223452 — Nitronox Scavenger Plus (March 5, 2023)
  • K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2) (December 4, 2020)
  • K160950 — MINISCAV (May 5, 2017)
  • K142138 — ISO-GARD MASK (October 30, 2014)
  • K132729 — ISO-GARD MASK (January 9, 2014)
  • K123176 — ISO-GARD CLEARAIR MASK (February 14, 2013)
  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)
  • K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (April 14, 2008)
  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)
  • K063519 — DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (December 1, 2006)

FDA data resources