Cleared Traditional

K900127 - FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS)

K900127 is an FDA 510(k) clearance for FERRIS HYDROPHILIC DRESSING (ADD'L INDI..., manufactured by Ferris Mfg. Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K900127 · Ferris Mfg. Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
129d
Days
Class 1
Risk

K900127 is an FDA 510(k) clearance for the FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS). Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Ferris Mfg. Corp. (Burr Ridge, US). The FDA issued a Cleared decision on May 18, 1990 after a review of 129 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 Ferris Mfg. Corp. devices

FDA 510(k) Submission Details - K900127

510(k) Number K900127 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 09, 1990
Decision Date May 18, 1990
Days to Decision 129 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 115d · This submission: 129d
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 148
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K900127.
MODIFIED LYOFOAM WOUND DRESSINGS
K895764 · Acme United Corp. · Sep 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · Smith & Nephew United, Inc. · Jun 1990
INTRASITE GEL (LABELING REVISION)
K901878 · Smith & Nephew United, Inc. · Jun 1990
DUODERM* CONTROL GEL FORMULA BORDER DRESSING
K901155 · Convatec, A Division of E.R. Squibb & Sons · Apr 1990
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
K895819 · Medi-Tech, Inc. · Nov 1989
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982