Cleared Traditional

HARRISON HAND HELD ADJUSTING INSTRUMENT (K010851) - FDA 510(k) Clearance

K010851 · Harrison Cbp Seminars · Physical Medicine device
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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

Submission Details

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.

Device Classification

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