Cleared Traditional

K905040 - ALGINATE FIBER

K905040 · Shepherd Medical Corp. · General & Plastic Surgery device
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Aug 1991
Decision
288d
Days
-
Risk

K905040 is an FDA 510(k) clearance for the ALGINATE FIBER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Shepherd Medical Corp. (Alexandria, US). The FDA issued a Cleared decision on August 21, 1991 after a review of 288 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 Shepherd Medical Corp. devices

FDA 510(k) Submission Details - K905040

510(k) Number K905040 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 06, 1990
Decision Date August 21, 1991
Days to Decision 288 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
173d slower than avg
Panel avg: 115d · This submission: 288d
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 597
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K905040.
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993
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
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990