Cleared Traditional

K984564 - ETHYL CHLORIDE DISPENSER

K984564 · Dukal Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
344d
Days
-
Risk

K984564 is an FDA 510(k) clearance for the ETHYL CHLORIDE DISPENSER. Classified as Vapocoolant Device (product code MLY).

Submitted by Dukal Corp. (New Port Riche, US). The FDA issued a Cleared decision on December 2, 1999 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K984564

510(k) Number K984564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date December 02, 1999
Days to Decision 344 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
228d slower than avg
Panel avg: 116d · This submission: 344d
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 K984564.
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
K002596 · Gebauer Co. · Feb 2001
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
K001624 · Gebauer Co. · Jan 2001
DERMAFREEZE
K992286 · Rhealm Pharmaceuticals, Inc. · Jan 2000
GEBAUER'S CHLORIDE FINE NOZZE
K991514 · Gebauer Co. · Jul 1999
FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE
K930915 · Gebauer Co. · Sep 1994
K984564 · ETHYL CHLORIDE DISPENSER
Download PDF FDA Summary Dukal Corp.