Cleared Traditional

K801884 - OP-SITE SKIN CLOSURE SUTURE ADHESIVE

K801884 is the FDA 510(k) clearance for OP-SITE SKIN CLOSURE SUTURE ADHESIVE by Acme United Corp.. It is a Class 1 General & Plastic Surgery device (product code FPX) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K801884 · Acme United Corp. · General & Plastic Surgery device
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Oct 1980
Decision
64d
Days
Class 1
Risk

K801884 is an FDA 510(k) clearance for the OP-SITE SKIN CLOSURE SUTURE ADHESIVE. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Acme United Corp. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 64 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 Acme United Corp. devices

Submission Details

510(k) Number K801884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1980
Decision Date October 10, 1980
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K801884.
ELASTOPLAST T.P.N.
K831439 · Beiersdorf, Inc. · Sep 1983
CENTRAL VENOUS CATHETER DRESSING TRAY
K802384 · American Medical Disposable, Inc. · Nov 1980
CUSTOM DRESSING TRAY-WET TO DRY/MASS.
K802385 · American Medical Disposable, Inc. · Nov 1980
FIXOMULL
K792725 · Beiersdorf, Inc. · Mar 1980
LEUKOFIX POROS
K792726 · Beiersdorf, Inc. · Feb 1980
HYPO-ALLERGENIC PLASTIC TAPE
K792136 · National Patent Development Corp. · Jan 1980