Cleared Traditional

K926463 - RITTERMODEL 75 EVOLUTION UNIV POW EXAM ...

K926463 is the FDA 510(k) clearance for RITTERMODEL 75 EVOLUTION UNIV POW EXAM ... by Midmark Corp.. It is a Class 1 General & Plastic Surgery device (product code FQO) cleared through the Traditional 510(k) pathway after a 666-day FDA review.

K926463 · Midmark Corp. · General & Plastic Surgery device
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Oct 1994
Decision
666d
Days
Class 1
Risk

K926463 is an FDA 510(k) clearance for the RITTERMODEL 75 EVOLUTION UNIV POW EXAM TABLE/ACCES. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on October 21, 1994 after a review of 666 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - the FDA general and plastic surgery 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Midmark Corp. devices

Submission Details

510(k) Number K926463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1992
Decision Date October 21, 1994
Days to Decision 666 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
551d slower than avg
Panel avg: 115d · This submission: 666d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FQO Table, Operating-room, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FQO Table, Operating-room, Ac-powered

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