Cleared Traditional

K803115 - DRESSING CHANGE FOR G TUBE

K803115 · American Medical Disposable, Inc. · General & Plastic Surgery device

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Jan 1981

Decision

27d

Days

Risk

K803115 is an FDA 510(k) clearance for the DRESSING CHANGE FOR G TUBE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 6, 1981 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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	K803115 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 10, 1980
Decision Date	January 06, 1981
Days to Decision	27 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

88d faster than avg

Panel avg: 115d · This submission: 27d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 222

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K803115.

DUODERM FLEXIBLE HYDROACTIVE DRESSINGS

K821656 · Convatec, A Division of E.R. Squibb & Sons · Sep 1982

PVP GEL DRESSING

K820635 · Johnson & Johnson Professionals, Inc. · Aug 1982

TEGADERM TRANSPARENT DRESSING

K812678 · 3M Company · Jan 1982

HYPERALIMENTATION DRESSING CHANGE TRAY

K803114 · American Medical Disposable, Inc. · Dec 1980

I.V. START KIT

K780222 · Marion Laboratories, Inc. · Mar 1978

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 K803115

American Medical Disposable, Inc.

Mchenry, IL · US

Regulatory profile

33 submissions 33 cleared

100% 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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