Cleared Traditional

K033720 - ARI COLD SPRAY

K033720 · Ari · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
562d
Days
-
Risk

K033720 is an FDA 510(k) clearance for the ARI COLD SPRAY. Classified as Vapocoolant Device (product code MLY).

Submitted by Ari (Marietta, US). The FDA issued a Cleared decision on June 10, 2005 after a review of 562 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

FDA 510(k) Submission Details - K033720

510(k) Number K033720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date June 10, 2005
Days to Decision 562 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
446d slower than avg
Panel avg: 116d · This submission: 562d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 24
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K031036 · Gebauer Co. · Jul 2003
K033720 · ARI COLD SPRAY
Download PDF FDA Summary Ari