Cleared Traditional

K905688 - CUTINOVA HYDRO

K905688 is an FDA 510(k) clearance for CUTINOVA HYDRO, manufactured by Beiersdorf, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KOZ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K905688 · Beiersdorf, Inc. · General & Plastic Surgery device
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Apr 1991
Decision
103d
Days
Class 1
Risk

K905688 is an FDA 510(k) clearance for the CUTINOVA HYDRO. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on April 1, 1991 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4018 - 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 Beiersdorf, Inc. devices

FDA 510(k) Submission Details - K905688

510(k) Number K905688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date April 01, 1991
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

KOZ Device Classification - Class 1, General Controls

Product Code KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4018
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 - KOZ Beads, Hydrophilic, For Wound Exudate Absorption

All 11
Devices cleared under the same product code (KOZ) and FDA review panel - the closest regulatory comparables to K905688.
INCARE PINSITE DRESSING
K905206 · Hollister, Inc. · Apr 1991
DERMASORB WOUND CONTACT LAYER DRESSING
K903645 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
ALLEVYN DRESSING CLAIMS CHANGE
K904412 · Smith & Nephew United, Inc. · Oct 1990
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION)
K901876 · Smith & Nephew United, Inc. · Jun 1990
INTRASITE CAVITY WOUND DRESSING
K895354 · Smith & Nephew United, Inc. · Nov 1989
ENVISAN PAD
K874552 · Marion Laboratories, Inc. · Jan 1988