Cleared Traditional

K830051 - MOLNLYCKE MESALT STERILE DRESSING

K830051 · Lada Intl., Inc. · General & Plastic Surgery device
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Jan 1983
Decision
16d
Days
-
Risk

K830051 is an FDA 510(k) clearance for the MOLNLYCKE MESALT STERILE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Lada Intl., Inc. (Walker, US). The FDA issued a Cleared decision on January 26, 1983 after a review of 16 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 Lada Intl., Inc. devices

Submission Details

510(k) Number K830051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1983
Decision Date January 26, 1983
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 194
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K830051.
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 1984
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708 · Convatec, A Division of E.R. Squibb & Sons · May 1983
DUODERM HYDROACTIVE GRANULES
K821655 · Convatec, A Division of E.R. Squibb & Sons · Oct 1982
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K821656 · Convatec, A Division of E.R. Squibb & Sons · Sep 1982
PVP GEL DRESSING
K820635 · Johnson & Johnson Professionals, Inc. · Aug 1982