Cleared Traditional

K980209 - SIMPLICARE THIN FILM WOUND DRESSINGS

K980209 · Hollister, Inc. · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Feb 1998

Decision

31d

Days

Risk

K980209 is an FDA 510(k) clearance for the SIMPLICARE THIN FILM WOUND DRESSINGS. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 31 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K980209

510(k) Number	K980209 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received	January 20, 1998
Decision Date	February 20, 1998
Days to Decision	31 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

84d faster than avg

Panel avg: 115d · This submission: 31d

Pathway characteristics

Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code	MGP Dressing, Wound And Burn, Occlusive
Device Class	-

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 57

Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K980209.

BTF THIN FILM WOUND DRESSING

K982939 · Bioderm, Inc. · Oct 1998

CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0

K981713 · Smith & Nephew, Inc. · Jul 1998

INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING

K981753 · Innovative Technologies , Ltd. · Jun 1998

SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM

K974520 · Innovative Technologies (Us), Inc. · Feb 1998

N-TERFACE

K973538 · Winfield Laboratories, Inc. · Dec 1997

ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING

K973657 · Maersk Medical, Ltd. · Dec 1997

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 K980209

Hollister, Inc.

Libertyville, IL · US

JOSEPH S TOKARZ

Regulatory profile

85 submissions 78 cleared

92% 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: February 20, 1998. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,972

Regulatory data since 1976

FDA monthly sync September 21, 2026