Cleared Traditional

K991214 - SIMPLICARE TRANSPARENT WOUND DRESSING

K991214 · Hollister, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
188d
Days
-
Risk

K991214 is an FDA 510(k) clearance for the SIMPLICARE TRANSPARENT WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 188 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Hollister, Inc. devices

FDA 510(k) Submission Details - K991214

510(k) Number K991214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1999
Decision Date October 14, 1999
Days to Decision 188 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
73d slower than avg
Panel avg: 115d · This submission: 188d
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 K991214.
FASTSEAL CHEST WOUND DRESSING
K990079 · Greenfield Medical Technologies, Inc. · Dec 1999
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
K992302 · Dermaphylyx, Inc. · Sep 1999
GILTECH PLUS TRANSPARENT DRESSING
K992005 · Giltech Plus, Inc. · Sep 1999
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
K990875 · Dermaphylyx, Inc. · May 1999
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING
K990438 · Dermaphylyx, Inc. · Mar 1999
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · Molnlycke Health Care, Inc. · Mar 1999