Cleared Traditional

K873332 - MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM

K873332 is an FDA 510(k) clearance for MAXIVAC(TM) CLOSED WOUND SUCTION DRAINA..., manufactured by American V. Mueller. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K873332 · American V. Mueller · General & Plastic Surgery device
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Sep 1987
Decision
20d
Days
Class 1
Risk

K873332 is an FDA 510(k) clearance for the MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by American V. Mueller (Chicago, US). The FDA issued a Cleared decision on September 8, 1987 after a review of 20 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 American V. Mueller devices

FDA 510(k) Submission Details - K873332

510(k) Number K873332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1987
Decision Date September 08, 1987
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 51
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K873332.
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
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
K863482 · Cardio Metrics, Inc. · Oct 1986
URESIL 150CC BELLOWS RESERVOIR
K863562 · Uresil Corp. · Sep 1986
URESIL CLOSED DRAINAGE RESERVOIR
K863505 · Uresil Corp. · Sep 1986