Cleared Traditional

K991729 - FERRIS POLYOSTOMY STERILE WOUND DRESSING

K991729 is an FDA 510(k) clearance for FERRIS POLYOSTOMY STERILE WOUND DRESSING, 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 99-day FDA review.

K991729 · Ferris Mfg. Corp. · General & Plastic Surgery device
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Aug 1999
Decision
99d
Days
Class 1
Risk

K991729 is an FDA 510(k) clearance for the FERRIS POLYOSTOMY STERILE WOUND DRESSING. 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 August 27, 1999 after a review of 99 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 - K991729

510(k) Number K991729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1999
Decision Date August 27, 1999
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
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 K991729.
MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
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K040779 · Hollister, Inc. · May 2004
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
K992032 · Acrymed, Inc. · Aug 1999
DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
K991920 · Dermaphylyx, Inc. · Aug 1999
DERMAPHYLYX FOAM ISLAND DRESSING
K991933 · Dermaphylyx, Inc. · Jul 1999