Cleared Traditional

K870941 - PHARMASEAL WOUND CARE DRESSING PAD

K870941 is an FDA 510(k) clearance for PHARMASEAL WOUND CARE DRESSING PAD, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 General & Plastic Surgery device with product code KOZ cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K870941 · American Pharmaseal Div. Ahsc · General & Plastic Surgery device
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Mar 1987
Decision
18d
Days
Class 1
Risk

K870941 is an FDA 510(k) clearance for the PHARMASEAL WOUND CARE DRESSING PAD. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on March 27, 1987 after a review of 18 days - a notably fast clearance cycle.

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: 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K870941

510(k) Number K870941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1987
Decision Date March 27, 1987
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 K870941.
ENVISAN PAD
K874552 · Marion Laboratories, Inc. · Jan 1988
DEBRISAN ABSORBENT PAD
K872453 · Pharmacia, Inc. · Jan 1988
ENVISAN PASTE
K874553 · Marion Laboratories, Inc. · Dec 1987
COMFEEL POWDER
K834343 · Coloplast A/S · Nov 1984
HOLLISTER WOUND EXUDATE ABSORBER
K820160 · Hollister, Inc. · Apr 1982