Cleared Traditional

ACU-DERM TRANSPARENT IV DRESSING (K842064) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K842064 · Acme United Corp. · General & Plastic Surgery device
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Aug 1984
Decision
86d
Days
Class 1
Risk

K842064 is an FDA 510(k) clearance for the ACU-DERM TRANSPARENT IV DRESSING. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Acme United Corp. (Mchenry, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5210 - 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 K842064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1984
Decision Date August 15, 1984
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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 - KMK Device, Intravascular Catheter Securement

Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K842064.
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
K180994 · Interrad Medical, Inc. · Jul 2019
DESERET POSITIONAL SUTURE WING
K915495 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
ADHESIVE I.V. CATHETER DRESSING
K810579 · Johnson & Johnson Professionals, Inc. · Mar 1981