Cleared Traditional

K991514 - GEBAUER'S CHLORIDE FINE NOZZE

K991514 · Gebauer Co. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
77d
Days
-
Risk

K991514 is an FDA 510(k) clearance for the GEBAUER'S CHLORIDE FINE NOZZE. Classified as Vapocoolant Device (product code MLY).

Submitted by Gebauer Co. (Cleveland, US). The FDA issued a Cleared decision on July 16, 1999 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K991514

510(k) Number K991514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1999
Decision Date July 16, 1999
Days to Decision 77 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
39d faster than avg
Panel avg: 116d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -
K991514 · GEBAUER'S CHLORIDE FINE NOZZE
Download PDF FDA Summary Gebauer Co.