Cleared Traditional

K890107 - GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT

K890107 · Premium Plastics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
286d
Days
-
Risk

K890107 is an FDA 510(k) clearance for the GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Premium Plastics, Inc. (Elkhorn, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 286 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 Premium Plastics, Inc. devices

FDA 510(k) Submission Details - K890107

510(k) Number K890107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received January 11, 1989
Decision Date October 24, 1989
Days to Decision 286 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
171d slower than avg
Panel avg: 115d · This submission: 286d
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 586
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K890107.
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990
KALTOCARB WOUND DRESSING
K894347 · Calgon Vestal Div. · Aug 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · Smith & Nephew United, Inc. · Aug 1989
KALTOSTAT WOUND PACKING
K892868 · Calgon Vestal Div. · Jul 1989