Cleared Traditional

THALAFIX NATURAL SEA SALT DRESSING (K980779) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K980779 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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Jun 1998
Decision
116d
Days
Class 1
Risk

K980779 is an FDA 510(k) clearance for the THALAFIX NATURAL SEA SALT DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on June 26, 1998 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. 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 Dumex Medical Surgical Products, Ltd. devices

Submission Details

510(k) Number K980779 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 02, 1998
Decision Date June 26, 1998
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 15
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K980779.
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · 3M Company · Oct 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982