Cleared Traditional

K201248 - Syringe Holder accessory

K201248 · Vapocoolshot, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
93d
Days
-
Risk

K201248 is an FDA 510(k) clearance for the Syringe Holder accessory. Classified as Vapocoolant Device (product code MLY).

Submitted by Vapocoolshot, Inc. (Jupiter, US). The FDA issued a Cleared decision on August 12, 2020 after a review of 93 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

FDA 510(k) Submission Details - K201248

510(k) Number K201248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2020
Decision Date August 12, 2020
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

MLY Device Classification - Class 0,

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.

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All 7
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