Cleared Traditional

K000487 - MEDTRADE PRODUCTS ALGINATE ISLAND

K000487 · Medtrade Products , Ltd. · General & Plastic Surgery device
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Apr 2000
Decision
64d
Days
-
Risk

K000487 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS ALGINATE ISLAND. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on April 18, 2000 after a review of 64 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 Medtrade Products , Ltd. devices

FDA 510(k) Submission Details - K000487

510(k) Number K000487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2000
Decision Date April 18, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 179
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K000487.
FORTADERM WOUND DRESSING
K011026 · Organogenesis, Inc. · Jun 2001
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
K003134 · Adri/Technam · Dec 2000
COLLAGEN WOUND DRESSING
K002443 · Oasis Research, LLC · Oct 2000
HYCURE ORAL / HYCURE ORAL SMART GEL
K994339 · The Hymed Group Corp. · Mar 2000
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
K000054 · Adri · Mar 2000
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000