Cleared Traditional

K881012 - WOUND-EVAC RS

K881012 is an FDA 510(k) clearance for WOUND-EVAC RS, manufactured by Heritage Medical Products. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K881012 · Heritage Medical Products · General & Plastic Surgery device
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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

FDA 510(k) Submission Details - K881012

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.

GCY Device Classification - Class 1, General Controls

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 52
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K881012.
CLOSED WOUND RESERVOIR
K896803 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
CLOSED WOUND SUCTION DEVICE
K883472 · Westmark, Sterile Packing Systems, Inc. (Sps) · Oct 1988
AMBU TWIN PUMP - (MANUAL SUCTION PUMP)
K883433 · Ambu, Inc. · Sep 1988
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K880650 · Baxter Healthcare Corp · Feb 1988
MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM
K873332 · American V. Mueller · Sep 1987
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
K863482 · Cardio Metrics, Inc. · Oct 1986