Cleared Traditional

FORMOSTAR (K862106) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862106 · Lmv, Liske & Methling, GmbH · Physical Medicine device
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Aug 1986
Decision
80d
Days
Class 2
Risk

K862106 is an FDA 510(k) clearance for the FORMOSTAR. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Lmv, Liske & Methling, GmbH (Hamburg 76, W.-Germany, DE). The FDA issued a Cleared decision on August 21, 1986 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - the FDA physical medicine device framework. 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 Lmv, Liske & Methling, GmbH devices

Submission Details

510(k) Number K862106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1986
Decision Date August 21, 1986
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.