Cleared Traditional

K010851 - HARRISON HAND HELD ADJUSTING INSTRUMENT

K010851 · Harrison Cbp Seminars · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
181d
Days
-
Risk

K010851 is an FDA 510(k) clearance for the HARRISON HAND HELD ADJUSTING INSTRUMENT. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Harrison Cbp Seminars (Evanston, US). The FDA issued a Cleared decision on September 18, 2001 after a review of 181 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. 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 Harrison Cbp Seminars devices

FDA 510(k) Submission Details - K010851

510(k) Number K010851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2001
Decision Date September 18, 2001
Days to Decision 181 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

Product Code LXM Manipulator, Plunger-like Joint
Device Class -

Regulatory Peers - LXM Manipulator, Plunger-like Joint

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