Cleared Traditional

K030281 - CRYOTRON 2 CRYOTHERAPY DEVICE

K030281 · Cryonic Medical North America · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
205d
Days
-
Risk

K030281 is an FDA 510(k) clearance for the CRYOTRON 2 CRYOTHERAPY DEVICE. Classified as Vapocoolant Device (product code MLY).

Submitted by Cryonic Medical North America (Montecito, US). The FDA issued a Cleared decision on August 20, 2003 after a review of 205 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.

View all Cryonic Medical North America devices

FDA 510(k) Submission Details - K030281

510(k) Number K030281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date August 20, 2003
Days to Decision 205 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
90d slower than avg
Panel avg: 115d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 14
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K030281.
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
K172598 · Itw Contamination Control Electronics · Apr 2018
Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
K172028 · Gebauer Company · Oct 2017
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
K172203 · Nuance Medical, LLC · Oct 2017
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