Cleared Traditional

K803114 - HYPERALIMENTATION DRESSING CHANGE TRAY

K803114 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Dec 1980
Decision
12d
Days
-
Risk

K803114 is an FDA 510(k) clearance for the HYPERALIMENTATION DRESSING CHANGE TRAY. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 12 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

FDA 510(k) Submission Details - K803114

510(k) Number K803114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1980
Decision Date December 22, 1980
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 501
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K803114.
PVP GEL DRESSING
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TEGADERM TRANSPARENT DRESSING
K812678 · 3M Company · Jan 1982
DRESSING CHANGE FOR G TUBE
K803115 · American Medical Disposable, Inc. · Jan 1981
ZINC PASTE BANDAGE
K802791 · Secol Co. · Dec 1980
JELONET PARAFFIN GAUZE DRESSINGS
K791573 · Acme United Corp. · Sep 1979
I.V. START KIT
K780222 · Marion Laboratories, Inc. · Mar 1978