Cleared Traditional

VARIODRAIN (K810636) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K810636 · Colmed, Ltd. · General & Plastic Surgery device
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May 1981
Decision
52d
Days
Class 1
Risk

K810636 is an FDA 510(k) clearance for the VARIODRAIN. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981 after a review of 52 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 Colmed, Ltd. devices

Submission Details

510(k) Number K810636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1981
Decision Date May 01, 1981
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 18
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K810636.
STRYKER CONSTAVAC
K823284 · Stryker Corp. · Jan 1983
ARGYLE VAC-U-CARE 100CC SUCTION RESERV
K821563 · Sherwood Medical Co. · Jun 1982
DEPUY HEMODRAIN
K811557 · Depuy, Inc. · Jul 1981
FRAZIER-FERGUSON SUCTION TUBES (DISP.)
K801612 · Edward Weck, Inc. · Aug 1980
ARGYLE VAC-U-CARE FLAT SILICONE WOUND T.
K801371 · Sherwood Medical Co. · Jun 1980
ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR
K801372 · Sherwood Medical Co. · Jun 1980