VAPOR-CLEAR, MODEL 100— 510(k) K092031

Substantially Equivalent

Axon Medical, Inc.

FDA 510(k) clearance K092031 for VAPOR-CLEAR, MODEL 100, Substantially Equivalent on 2010-04-16. Applicant: Axon Medical, Inc.. Device class: 2.

Clearance details

Applicant: Axon Medical, Inc.
Product code: Code CBN
Device class: Class 2
Regulation: 21 CFR 868.5430
Advisory panel: Anesthesiology
Date received: 2009-07-06
Decision date: 2010-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park City, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K092031

K-number listed on FDA's recall record

Z-1591-2023 — Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.Class II·Ongoing·Dynasthetics LLC·20220509

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092031.

Data sourced from openFDA. This site is unofficial and independent of the FDA.