Cleared Traditional

K182163 - Shear Stress Therapeutics SST 3000

K182163 is an FDA 510(k) clearance for Shear Stress Therapeutics SST 3000, manufactured by Shear Stress Therapeutics, LLC. The device is a Class 2 Physical Medicine device with 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

FDA 510(k) Submission Details - K182163

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.

IPF Device Classification - Class 2, Special Controls

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 257
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K182163.
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K181688 · Shenzhen Roundwhale Technology Co. , Ltd. · Sep 2018
geko T-3 Neuromuscular Stimulator
K181059 · Firstkind Limited · May 2018