Cleared Traditional

K182163 - Shear Stress Therapeutics SST 3000

K182163 is the FDA 510(k) clearance for Shear Stress Therapeutics SST 3000 by Shear Stress Therapeutics, LLC. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K182163 · Shear Stress Therapeutics, LLC · Physical Medicine device
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Jul 2019
Decision
333d
Days
Class 2
Risk

K182163 is an FDA 510(k) clearance for the Shear Stress Therapeutics SST 3000. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Shear Stress Therapeutics, LLC (Tulsa, US). The FDA issued a Cleared decision on July 9, 2019 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - 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. Elevated predicate reliance profile. 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 Shear Stress Therapeutics, LLC devices

Submission Details

510(k) Number K182163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2018
Decision Date July 09, 2019
Days to Decision 333 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 115d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 - IPF Stimulator, Muscle, Powered

All 134
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K182163.
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K181059 · Firstkind Limited · May 2018