Cleared Traditional

K782028 - ROUND SILICONE DRAIN

K782028 is the FDA 510(k) clearance for ROUND SILICONE DRAIN by Davol, Inc.. It is a Class 1 General & Plastic Surgery device (product code GCY) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K782028 · Davol, Inc. · General & Plastic Surgery device

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Dec 1978

Decision

15d

Days

Class 1

Risk

K782028 is an FDA 510(k) clearance for the ROUND SILICONE DRAIN. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Davol, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 15 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 Davol, Inc. devices

Submission Details

510(k) Number	K782028 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 05, 1978
Decision Date	December 20, 1978
Days to Decision	15 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

100d faster than avg

Panel avg: 115d · This submission: 15d

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 36

Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K782028.

ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR

K801372 · Sherwood Medical Co. · Jun 1980

DAVOL/ABAMSON SILICONE SUMP DRAIN

K800081 · Davol, Inc. · Jan 1980

CLOSED WOUND VACUUM DRAINAGE SYSTEM

K790654 · 3M Company · Apr 1979

FLAT SILICONE DRAIN

K782026 · Davol, Inc. · Dec 1978

PORTABLE CLOSED WOUND SUCTION EVACUATOR

K780848 · Biomet, Inc. · Aug 1978

ARGYLE SUCTION CONTROL KIT

K760601 · Sherwood Medical Co. · Nov 1976

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K782028

Davol, Inc.

Mchenry, IL · US

Regulatory profile

50 submissions 47 cleared

94% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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