Cleared Traditional

K942959 - KIT PAK WET SALINE DRESSING

K942959 · Kit Pak, Inc. · General & Plastic Surgery device
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Feb 1995
Decision
236d
Days
-
Risk

K942959 is an FDA 510(k) clearance for the KIT PAK WET SALINE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Kit Pak, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on February 14, 1995 after a review of 236 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 Kit Pak, Inc. devices

Submission Details

510(k) Number K942959 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1994
Decision Date February 14, 1995
Days to Decision 236 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
121d slower than avg
Panel avg: 115d · This submission: 236d
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 K942959.
RECLOSABLE WOUND COVER
K954621 · Hollister, Inc. · Oct 1995
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · Hollister, Inc. · Oct 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
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
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990