510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100364Substantially Equivalent

Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520

Gambro Renal Products, Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100364 is the FDA 510(k) clearance record for GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520, a class II device, cleared for Gambro Renal Products, Inc. on under FDA product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve). FDA records list 37 510(k) clearances for Gambro Renal Products, Inc., from to . As of , FDA records show 5 recalls naming K100364.

Clearance record

Decision date
Received
(264 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
Gambro Renal Products, Inc. 14143 Denver W. Pkwy., Lakewood CO
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