Cleared Traditional

K201248 - Syringe Holder accessory (FDA 510(k) Clearance)

K201248 · Vapocoolshot, Inc. · Physical Medicine device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -