Cleared Traditional

K942459 - CURASALT HYPERTONIC SALINE DRESSING

K942459 is an FDA 510(k) clearance for CURASALT HYPERTONIC SALINE DRESSING, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K942459 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
34d
Days
Class 1
Risk

K942459 is an FDA 510(k) clearance for the CURASALT HYPERTONIC SALINE DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on June 27, 1994 after a review of 34 days - a notably fast clearance cycle.

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: 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 Kendall Healthcare Products Co. Div.Of Tyco Health devices

FDA 510(k) Submission Details - K942459

510(k) Number K942459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1994
Decision Date June 27, 1994
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

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 91
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K942459.
SAF-GEL HYDRATING DERMAL WOUND DRESSING
K942270 · Calgon Vestal Div. · Aug 1994
HYDROCOLLOID WOUND DRESSING
K943258 · Convatec, A Division of E.R. Squibb & Sons · Aug 1994
HYPERTONIC SALINE WET DRESSING - STERILE
K941999 · Trinity Laboratories, Inc. · Jun 1994
FERRIS POLYMEM HYDROPHILIC WOUND DRESSING
K932913 · Ferris Mfg. Corp. · Jun 1994
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons · Jan 1994