Cleared Traditional

HYPERALIMENTATION DRESSING CHANGE TRAY (K803114) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 115d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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