Cleared Traditional

K082218 - MAX ADJUSTING INSTRUMENT

K082218 · Manna Omni International, Inc. · Physical Medicine device

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Aug 2008

Decision

Days

Risk

K082218 is an FDA 510(k) clearance for the MAX ADJUSTING INSTRUMENT. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Manna Omni International, Inc. (Fullerton, US). The FDA issued a Cleared decision on August 13, 2008 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082218

510(k) Number	K082218 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 06, 2008
Decision Date	August 13, 2008
Days to Decision	7 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

109d faster than avg

Panel avg: 116d · This submission: 7d

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 30

Devices cleared under the same product code (LXM) and FDA review panel - the closest regulatory comparables to K082218.

VSTAAR AdjusteR

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K130666 · Optima Health Solutions International Corporation · Jan 2014

ACTIVATOR V-E

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IMPULSE IQ ADJUSTING INSTRUMENT

K080261 · Neuromechanical Innovations, LLC · Apr 2008

ACTIVATOR V SPINAL ADJUSTING INSTRUMENT

K072519 · Activator Methods International, Ltd. · Oct 2007

KHAN KINETIC TREATMENT DEVICE (KKT-M1)

K060043 · Optima Health Solutions International, Inc. · Mar 2006

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 K082218

Manna Omni International, Inc.

Fullerton, CA · US

STEPHEN TSAI

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Manna Omni International, Inc. →

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: August 13, 2008. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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