Cleared Traditional

K010851 - HARRISON HAND HELD ADJUSTING INSTRUMENT

K010851 · Harrison Cbp Seminars · Physical Medicine device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

65d slower than avg

Panel avg: 116d · 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

All 31

Devices cleared under the same product code (LXM) and FDA review panel - the closest regulatory comparables to K010851.

TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)

K050428 · Advanced Spinal Technologies, Inc. · Jun 2005

IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003

K023462 · Neuromechanical Innovations, LLC · Jan 2003

FRYE ADJUSTING INSTRUMENT

K021238 · Frye Health Systems · Oct 2002

FS ACTIVATOR III

K003185 · Activator Methods International, Ltd. · Mar 2001

TORQUE INSTRUMENT, MODEL 8500

K001476 · Spinalight, Inc. · Aug 2000

SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR

K973914 · Sense Technology, Inc. · Jun 1998

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.

Manufacturer of K010851

Harrison Cbp Seminars

Evanston, WY · US

SANG HARRISON

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Harrison Cbp Seminars →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: September 18, 2001. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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