Cleared Traditional

K990891 - DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING

K990891 · Dermaphylyx, Inc. · General & Plastic Surgery device

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May 1999

Decision

71d

Days

Risk

K990891 is an FDA 510(k) clearance for the DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dermaphylyx, Inc. (Arvada, US). The FDA issued a Cleared decision on May 27, 1999 after a review of 71 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 Dermaphylyx, Inc. devices

FDA 510(k) Submission Details - K990891

510(k) Number	K990891 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	March 17, 1999
Decision Date	May 27, 1999
Days to Decision	71 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

44d faster than avg

Panel avg: 115d · This submission: 71d

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 324

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K990891.

ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING

K990810 · Maersk Medical, Ltd. · Sep 1999

SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN

K992363 · Euromed, Inc. · Aug 1999

SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA

K991287 · Advanced Medical Solutions Group Plc · Jun 1999

DUMEX IODOFORM PACKING STRIP

K990332 · Dumex Medical Surgical Products, Ltd. · Apr 1999

SILON DUAL-DRESS

K990042 · Bio Med Sciences, Inc. · Mar 1999

MODIFICATION OF CUTINOVA THIN DRESSING

K984593 · Beiersdorf-Jobt, Inc. · Mar 1999

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K990891

Dermaphylyx, Inc.

Arvada, CO · US

ANDREW M REED

Regulatory profile

9 submissions 7 cleared

78% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: May 27, 1999. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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