Cleared Traditional

MAX ADJUSTING INSTRUMENT (K082218) - FDA 510(k) Clearance

K082218 · Manna Omni International, Inc. · Physical Medicine device
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Aug 2008
Decision
7d
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.

View all Manna Omni International, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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