Cleared Traditional

K803116 - HEAVY DRAINAGE PACK

K803116 is the FDA 510(k) clearance for HEAVY DRAINAGE PACK by American Medical Disposable, Inc.. It is a Class 1 General & Plastic Surgery device (product code GEC) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K803116 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Jan 1981
Decision
49d
Days
Class 1
Risk

K803116 is an FDA 510(k) clearance for the HEAVY DRAINAGE PACK. Classified as Brush, Scrub, Operating-room (product code GEC), Class I - General Controls.

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Medical Disposable, Inc. devices

Submission Details

510(k) Number K803116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1980
Decision Date January 28, 1981
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEC Brush, Scrub, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - GEC Brush, Scrub, Operating-room

All 17
Devices cleared under the same product code (GEC) and FDA review panel - the closest regulatory comparables to K803116.
SCRUB MATE DRY STERILE SCRUB BRUSH
K844411 · American Sterilizer Co. · Dec 1984
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · The Kendal Co. · Jan 1982
DISPOSABLE SCRUB BRUSH
K810655 · Dexide, Inc. · May 1981
ANAGO ELECTRO SURGICAL TIP CLEANER
K800058 · Anago, Inc. · Jan 1980
DEXIDE DIS. SUR. SCRUB SPONGE W/PARACHLO
K792272 · Dexide, Inc. · Dec 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K792271 · Dexide, Inc. · Dec 1979