Cleared Traditional

K871255 - MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING

K871255 · Hercon Laboratories Corp. · General & Plastic Surgery device
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May 1987
Decision
59d
Days
-
Risk

K871255 is an FDA 510(k) clearance for the MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hercon Laboratories Corp. (So. Plainfield, US). The FDA issued a Cleared decision on May 29, 1987 after a review of 59 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 Hercon Laboratories Corp. devices

FDA 510(k) Submission Details - K871255

510(k) Number K871255 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 31, 1987
Decision Date May 29, 1987
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 601
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K871255.
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · Beiersdorf, Inc. · Jul 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · American Pharmaseal Div. Ahsc · Jun 1987
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES
K870184 · Fraass Survival Systems, Inc. · Feb 1987
COMPRESS AND BANDAGE, VARIOUS SIZES
K870241 · Fraass Survival Systems, Inc. · Feb 1987
FERRIS DYNADERM PLUS
K865089 · Ferris Mfg. Corp. · Feb 1987