Cleared Traditional

K101889 - DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE

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)
Optimized for regulatory review, auditing and printing
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.

View all Pivotal Health Solutions devices

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 116d · 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 Consultant

Intertek Testing Services
WILLIAM SAMMONS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITH Equipment, Traction, Powered

All 46
Devices cleared under the same product code (ITH) and FDA review panel - the closest regulatory comparables to K101889.
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INTEGRITY SPINAL CARE SYSTEM
K103248 · Integra Life Sciences · Apr 2011
MTD 4000
K091540 · Mettler Electronics Corp. · Oct 2009
TM-400
K081247 · Ito Co., Ltd. · Aug 2008
GRAVILAX TRACTION SYSTEM
K072064 · Therapeutic Clinical Technologies, Inc. · Apr 2008

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.