510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010264Substantially Equivalent

Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set

Nipro Medical Corporation, Weston FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010264 is the FDA 510(k) clearance record for NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET, a class II device, cleared for Nipro Medical Corp. on under FDA product code FIB (Protector, Transducer, Dialysis). FDA records list 62 510(k) clearances for Nipro Medical Corp., from to . As of , FDA records show no recalls naming K010264.

Clearance record

Decision date
Received
(88 days to decision)
Product code
FIB Protector, Transducer, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nipro Medical Corp. 510 Stonemont Dr., Weston FL
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