510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K072024Substantially Equivalent

Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693

Nipro Medical Corporation, Miami FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072024 is the FDA 510(k) clearance record for NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693, a class II device, cleared for Nipro Medical Corp. on under FDA product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve). FDA records list 62 510(k) clearances for Nipro Medical Corp., from to . As of , FDA records show one recall naming K072024.

Clearance record

Decision date
Received
(72 days to decision)
Product code
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Nipro Medical Corp. 3150 NW 107 Ave.,, Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FJK

Trailing 12 months
2 clearances under product code FJK in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FJK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260