510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053169Substantially Equivalent

Rm3 Renal Preservation System

Waters Instruments, Inc., Rochester MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053169 is the FDA 510(k) clearance record for RM3 RENAL PRESERVATION SYSTEM, a class II device, cleared for Waters Instruments, Inc. on under FDA product code KDK (Container, Transport, Kidney). FDA records list 12 510(k) clearances for Waters Instruments, Inc., from to . As of , FDA records show no recalls naming K053169.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KDK Container, Transport, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Waters Instruments, Inc. 2112 15th St. NW, Suite A, Rochester MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDK

Trailing 12 months

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

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