Cleared Traditional

K101889 - DECOMPRESSION OF CHOICE AND NEURO DECOM...

K101889 is an FDA 510(k) clearance for DECOMPRESSION OF CHOICE AND NEURO DECOM..., manufactured by Pivotal Health Solutions. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K101889 · Pivotal Health Solutions · Physical Medicine device
Download Printable Device Report (PDF)
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Aug 2010
Decision
51d
Days
Class 2
Risk

K101889 is an FDA 510(k) clearance for the DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Pivotal Health Solutions (Watertown, US). The FDA issued a Cleared decision on August 27, 2010 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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FDA 510(k) Submission Details - K101889

510(k) Number K101889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2010
Decision Date August 27, 2010
Days to Decision 51 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ITH Device Classification - Class 2, Special Controls

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 - ITH Equipment, Traction, Powered

All 11
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