Cleared Traditional

TECNOL SALINE WET DRESSING (K954243) - FDA 510(k) Clearance

K954243 · Tecnol Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
79d
Days
-
Risk

K954243 is an FDA 510(k) clearance for the TECNOL SALINE WET DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Tecnol Medical Products, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 79 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 Tecnol Medical Products, Inc. devices

Submission Details

510(k) Number K954243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1995
Decision Date November 29, 1995
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K954243.
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005
ACTICOAT MOISTURE CONTROL DRESSING
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3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · Baxter Healthcare Corp · Dec 1988