510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001971Substantially Equivalent

Hemodialysis Tubing Sets

Ofi Biomedica S.p.A., North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001971 is the FDA 510(k) clearance record for HEMODIALYSIS TUBING SETS, a class II device, cleared for Ofi Biomedica S.P.A. on under FDA product code FIB (Protector, Transducer, Dialysis). FDA records list one 510(k) clearance for Ofi Biomedica S.P.A. As of , FDA records show no recalls naming K001971.

Clearance record

Decision date
Received
(330 days to decision)
Product code
FIB Protector, Transducer, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ofi Biomedica S.P.A. 49 Plain St., North Attleboro MA
510(k) summary
Summary
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