Cleared Traditional

Vapocoolshot Mist (K193349) - FDA 510(k) Clearance

K193349 · Vapocoolshot, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
133d
Days
-
Risk

K193349 is an FDA 510(k) clearance for the Vapocoolshot Mist. Classified as Vapocoolant Device (product code MLY).

Submitted by Vapocoolshot, Inc. (Jupiter, US). The FDA issued a Cleared decision on April 14, 2020 after a review of 133 days - within the typical 510(k) review window.

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 Vapocoolshot, Inc. devices

Submission Details

510(k) Number K193349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2019
Decision Date April 14, 2020
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Consultant

N2pharma, LLC
Neil Ross

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MLY Vapocoolant Device

All 7
Devices cleared under the same product code (MLY) and FDA review panel - the closest regulatory comparables to K193349.
CRYO Arctic, CRYO Penguin
K203661 · Cryoscience North America, Inc. · May 2022
num Vapocoolant
K202782 · 623 Medical, LLC · Dec 2020
Syringe Holder accessory
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Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
K190161 · Gebauer Company · May 2019
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
K172598 · Itw Contamination Control Electronics · Apr 2018