510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121618Substantially Equivalent

Bel-Gen Cold Storage Solution

Waters Medical Systems LLC, Rochester MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121618 is the FDA 510(k) clearance record for BEL-GEN COLD STORAGE SOLUTION, a class II device, cleared for Waters Medical Systems, LLC on under FDA product code KDL (Set, Perfusion, Kidney, Disposable). FDA records list 3 510(k) clearances for Waters Medical Systems, LLC, from to . As of , FDA records show no recalls naming K121618.

Clearance record

Decision date
Received
(378 days to decision)
Product code
KDL Set, Perfusion, Kidney, Disposable
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Waters Medical Systems, LLC 2112 15th St. NW, Rochester MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDL

Trailing 12 months

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

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