510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844625Substantially Equivalent

Bipore o.2 Micron Hydrophobic Filter Assembly

Bipore, Inc., Demarest NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844625 is the FDA 510(k) clearance record for BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY, a class I device, cleared for Bipore, Inc. on under FDA product code KOZ (Beads, Hydrophilic, For Wound Exudate Absorption). FDA records list 10 510(k) clearances for Bipore, Inc., from to . As of , FDA records show no recalls naming K844625.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Regulation
21 CFR 878.4018
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Bipore, Inc. 16 Edward St., Demarest NJ
Third party review
No

Clearances, product code KOZ

Trailing 12 months

FDA records hold no clearances under product code KOZ in the trailing twelve months.

FDA records show no clearances under product code KOZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KOZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260