Cleared Traditional

K901109 - WOUND TREATMENT KIT

K901109 · Orion Life Systems, Inc. · General & Plastic Surgery device
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Jun 1990
Decision
89d
Days
-
Risk

K901109 is an FDA 510(k) clearance for the WOUND TREATMENT KIT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 6, 1990 after a review of 89 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.

FDA 510(k) Submission Details - K901109

510(k) Number K901109 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 09, 1990
Decision Date June 06, 1990
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K901109.
SPARTA WET DRESSING, SODIUM CHLORIDE
K922729 · Sparta Surgical Corp. · Nov 1992
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
MESALT STERILE DRESSING
K897142 · Scott Health Care · Mar 1990
WATER JEL STERILE GEL-SOAKED BURN DRESSING
K900516 · Trilling Medical Technologies, Inc. · Mar 1990
WOUND DRESSING
K896702 · Viaderm Pharmaceuticals, Inc. · Jan 1990
K901109 · WOUND TREATMENT KIT
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