Cleared Traditional

K864841 - WATER-JEL(R) BURN DRESSING

K864841 · Trilling Resources, Ltd. · General & Plastic Surgery device
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Jan 1988
Decision
409d
Days
-
Risk

K864841 is an FDA 510(k) clearance for the WATER-JEL(R) BURN DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Trilling Resources, Ltd. (Hartsdale, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 409 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Trilling Resources, Ltd. devices

FDA 510(k) Submission Details - K864841

510(k) Number K864841 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 09, 1986
Decision Date January 22, 1988
Days to Decision 409 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
294d slower than avg
Panel avg: 115d · This submission: 409d
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 K864841.
FERRIS HYDROPHILIC DRESSING
K880330 · Ferris Mfg. Corp. · Mar 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · Smith & Nephew, Inc. · Mar 1988
DERMATOLOGICAL PATCH
K872926 · Convatec, A Division of E.R. Squibb & Sons · Feb 1988
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID
K871675 · Ferris Mfg. Corp. · Aug 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987