510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862015Substantially Equivalent

o.2 Micron Infection Resistant Hydrophobic Filter

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

K862015 is the FDA 510(k) clearance record for O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER, a class II device, cleared for Bipore, Inc. on under FDA product code FIB (Protector, Transducer, Dialysis). FDA records list 10 510(k) clearances for Bipore, Inc., from to . As of , FDA records show no recalls naming K862015.

Clearance record

Decision date
Received
(55 days to decision)
Product code
FIB Protector, Transducer, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bipore, Inc. 16 Edward St., Demarest NJ
Third party review
No

Clearances, product code FIB

Trailing 12 months

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

FDA records show no clearances under product code FIB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FIB, 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