Cleared Traditional

WOUND-EVAC RS (K881012) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K881012 · Heritage Medical Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
7d
Days
Class 1
Risk

K881012 is an FDA 510(k) clearance for the WOUND-EVAC RS. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Heritage Medical Products (Tucker, US). The FDA issued a Cleared decision on March 17, 1988 after a review of 7 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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 Heritage Medical Products devices

Submission Details

510(k) Number K881012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date March 17, 1988
Days to Decision 7 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
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 17
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K881012.
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
K972703 · B.Braun Medical, Inc. · Oct 1997
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
K963839 · Cordis Corp. · Dec 1996
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K880650 · Baxter Healthcare Corp · Feb 1988
BARD PARKER 150CC BELLOWS RESERVOIR
K854424 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1985
ECONOMY 400 CWS WITH PVC DRAINS
K851084 · C.R. Bard, Inc. · Jun 1985
BBL STREP GROUPING KIT
K830510 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1983