Cleared Traditional

K001624 - GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

K001624 · Gebauer Co. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
244d
Days
-
Risk

K001624 is an FDA 510(k) clearance for the GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04. Classified as Vapocoolant Device (product code MLY).

Submitted by Gebauer Co. (Cleveland, US). The FDA issued a Cleared decision on January 25, 2001 after a review of 244 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K001624

510(k) Number K001624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2000
Decision Date January 25, 2001
Days to Decision 244 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 116d · This submission: 244d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 24
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K001624.
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
K031036 · Gebauer Co. · Jul 2003
GEBAUER'S INSTANT ICE
K021726 · Gebauer Co. · Dec 2002
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
K002596 · Gebauer Co. · Feb 2001
DERMAFREEZE
K992286 · Rhealm Pharmaceuticals, Inc. · Jan 2000
ETHYL CHLORIDE DISPENSER
K984564 · Dukal Corp. · Dec 1999
GEBAUER'S CHLORIDE FINE NOZZE
K991514 · Gebauer Co. · Jul 1999
K001624 · GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
Download PDF FDA Summary Gebauer Co.