Cleared Traditional

K971091 - OPPURTUNITY TRACHEOSTOMY CARE KIT

K971091 is an FDA 510(k) clearance for OPPURTUNITY TRACHEOSTOMY CARE KIT, manufactured by Opportunity, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K971091 · Opportunity, Inc. · General & Plastic Surgery device
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Sep 1997
Decision
176d
Days
Class 1
Risk

K971091 is an FDA 510(k) clearance for the OPPURTUNITY TRACHEOSTOMY CARE KIT. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Opportunity, Inc. (Highland Park, US). The FDA issued a Cleared decision on September 16, 1997 after a review of 176 days - an extended review 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: 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 Opportunity, Inc. devices

FDA 510(k) Submission Details - K971091

510(k) Number K971091 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 24, 1997
Decision Date September 16, 1997
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
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 107
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K971091.
ALGINATE/ZINC WOUND DRESSING
K973283 · Innovative Technologies , Ltd. · Oct 1997
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons · Oct 1997
OPPORTUNITY DRESSING CHANGE TRAY
K971090 · Opportunity, Inc. · Sep 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997
DERMAGRAN WOUND MANAGEMENT SYSTEM
K970660 · Derma Sciences, Inc. · Aug 1997
DERMAMEND HYDROGEL GAUZE DRESSING
K972336 · Dermarx Corp. · Jul 1997