Cleared Traditional

ETHYL CHLORIDE DISPENSER (K984564) - FDA 510(k) Clearance

K984564 · Dukal Corp. · Physical Medicine device
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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.

View all Dukal Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 115d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 22
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