Cleared Traditional

MULTIPLE OUTLET MANIFOLD (K850389) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K850389 · The Anspach Effort, Inc. · General & Plastic Surgery device
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Mar 1985
Decision
45d
Days
Class 1
Risk

K850389 is an FDA 510(k) clearance for the MULTIPLE OUTLET MANIFOLD. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by The Anspach Effort, Inc. (Lake Park, US). The FDA issued a Cleared decision on March 18, 1985 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 The Anspach Effort, Inc. devices

Submission Details

510(k) Number K850389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date March 18, 1985
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEY Motor, Surgical Instrument, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.