Cleared Traditional

K942959 - KIT PAK WET SALINE DRESSING

K942959 · Kit Pak, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K942959

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.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 586
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K942959.
HOLLISTER HYDROCOLLOID WOUND DRESSING
K954235 · Hollister, Inc. · Oct 1995
SALINE DRESSING
K952948 · Busse Hospital Disposables, Inc. · Aug 1995
HOLLISTER HYDROCOLLOID WOUND DRESSINGS
K950933 · Hollister, Inc. · Jul 1995
PREPPIES SKIN BARRIER WIPE
K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995
SPYROFILM IQ WOUND DRESSING(WITH INERT FILLER)
K932676 · Polymedica Industries, Inc. · Dec 1993
SALINE WET DRESSING- STERILE
K934258 · Trinity Laboratories, Inc. · Nov 1993