Cleared Traditional

K874291 - EPI-LOCK T.M. PRIMADERM

K874291 is an FDA 510(k) clearance for EPI-LOCK T.M. PRIMADERM, manufactured by Derma-Lock Medical Corp.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K874291 · Derma-Lock Medical Corp. · General & Plastic Surgery device
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Nov 1987
Decision
21d
Days
Class 1
Risk

K874291 is an FDA 510(k) clearance for the EPI-LOCK T.M. PRIMADERM. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Derma-Lock Medical Corp. (Englewood, US). The FDA issued a Cleared decision on November 10, 1987 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Derma-Lock Medical Corp. devices

FDA 510(k) Submission Details - K874291

510(k) Number K874291 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 20, 1987
Decision Date November 10, 1987
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K874291.
ENVICLUSIVE (TM)
K874554 · Marion Laboratories, Inc. · Mar 1988
PHARMACLUSIVE (TM)
K872573 · Pharmacia, Inc. · Feb 1988
DYNAFILM
K874478 · Ferris Mfg. Corp. · Jan 1988
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, Inc. · Sep 1987
STRETCH GAUZE BANDAGES
K872875 · Abco Dealers, Inc. · Sep 1987
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
K872982 · Johnson & Johnson Professionals, Inc. · Aug 1987