Cleared Traditional

K900405 - SCHOLTEN FRAME (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K900405 · Scholten Surgical Instruments, Inc. · General & Plastic Surgery device
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Mar 1990
Decision
31d
Days
Class 1
Risk

K900405 is an FDA 510(k) clearance for the SCHOLTEN FRAME. Classified as Table, Surgical With Orthopedic Accessories, Manual (product code JEB), Class I - General Controls.

Submitted by Scholten Surgical Instruments, Inc. (Oakland, US). The FDA issued a Cleared decision on March 1, 1990 after a review of 31 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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: 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 Scholten Surgical Instruments, Inc. devices

Submission Details

510(k) Number K900405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date March 01, 1990
Days to Decision 31 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 114d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JEB Table, Surgical With Orthopedic Accessories, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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.