Cleared Traditional

K802385 - CUSTOM DRESSING TRAY-WET TO DRY/MASS.

K802385 is an FDA 510(k) clearance for CUSTOM DRESSING TRAY-WET TO DRY/MASS., manufactured by American Medical Disposable, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FPX cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K802385 · American Medical Disposable, Inc. · General & Plastic Surgery device
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Nov 1980
Decision
41d
Days
Class 1
Risk

K802385 is an FDA 510(k) clearance for the CUSTOM DRESSING TRAY-WET TO DRY/MASS.. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by American Medical Disposable, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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

FDA 510(k) Submission Details - K802385

510(k) Number K802385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1980
Decision Date November 12, 1980
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

FPX Device Classification - Class 1, General Controls

Product Code FPX Strip, Adhesive, Closure, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - FPX Strip, Adhesive, Closure, Skin

All 20
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K802385.
ELASTOPLAST
K831438 · Beiersdorf, Inc. · Nov 1983
ELASTOPLAST T.P.N.
K831439 · Beiersdorf, Inc. · Sep 1983
CENTRAL VENOUS CATHETER DRESSING TRAY
K802384 · American Medical Disposable, Inc. · Nov 1980
OP-SITE SKIN CLOSURE SUTURE ADHESIVE
K801884 · Acme United Corp. · Oct 1980
FIXOMULL
K792725 · Beiersdorf, Inc. · Mar 1980
LEUKOFIX POROS
K792726 · Beiersdorf, Inc. · Feb 1980