Cleared Traditional

K844625 - BIPORE O.2 MICRON HYDROPHOBIC FILTER AS...

K844625 is the FDA 510(k) clearance for BIPORE O.2 MICRON HYDROPHOBIC FILTER AS... by Bipore, Inc.. It is a Class 1 General & Plastic Surgery device (product code KOZ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K844625 · Bipore, Inc. · General & Plastic Surgery device
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Jan 1985
Decision
50d
Days
Class 1
Risk

K844625 is an FDA 510(k) clearance for the BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Bipore, Inc. (Demarest, US). The FDA issued a Cleared decision on January 16, 1985 after a review of 50 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 Bipore, Inc. devices

Submission Details

510(k) Number K844625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1984
Decision Date January 16, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 12
Devices cleared under the same product code (KOZ) and FDA review panel - the closest regulatory comparables to K844625.
DEBRISAN ABSORBENT PAD
K872453 · Pharmacia, Inc. · Jan 1988
ENVISAN PASTE
K874553 · Marion Laboratories, Inc. · Dec 1987
PHARMASEAL WOUND CARE DRESSING PAD
K870941 · American Pharmaseal Div. Ahsc · Mar 1987
COMFEEL POWDER
K834343 · Coloplast A/S · Nov 1984
HOLLISTER WOUND EXUDATE ABSORBER
K820160 · Hollister, Inc. · Apr 1982