Cleared Traditional

K872094 - VACU-AIDE

K872094 is the FDA 510(k) clearance for VACU-AIDE by The Devilbiss Co.. It is a Class 2 General & Plastic Surgery device (product code JCX) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K872094 · The Devilbiss Co. · General & Plastic Surgery device
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Oct 1987
Decision
136d
Days
Class 2
Risk

K872094 is an FDA 510(k) clearance for the VACU-AIDE. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by The Devilbiss Co. (Somerset, US). The FDA issued a Cleared decision on October 15, 1987 after a review of 136 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K872094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date October 15, 1987
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.