Cleared Traditional

3M FUKUDA TYPE RING RETRACTOR (K852567) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K852567 · 3M Company · General & Plastic Surgery device
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Jul 1985
Decision
21d
Days
Class 1
Risk

K852567 is an FDA 510(k) clearance for the 3M FUKUDA TYPE RING RETRACTOR. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 3M Company devices

Submission Details

510(k) Number K852567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1985
Decision Date July 09, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.