Cleared Traditional

K251531 - AIR COMPRESSION BOOTS 1018195,1018196 (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251531 · Merchsource, LLC · Physical Medicine device
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Oct 2025
Decision
164d
Days
Class 2
Risk

K251531 is an FDA 510(k) clearance for the AIR COMPRESSION BOOTS 1018195,1018196. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Merchsource, LLC (Irvine, US). The FDA issued a Cleared decision on October 30, 2025 after a review of 164 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine device framework. 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 Merchsource, LLC devices

Submission Details

510(k) Number K251531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2025
Decision Date October 30, 2025
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 149
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K251531.
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