510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133724Substantially Equivalent

Minncare Hd

Medivators Inc, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133724 is the FDA 510(k) clearance record for MINNCARE HD, a class II device, cleared for Medivators, Inc. on under FDA product code NIH (Disinfectant, Subsystem, Water Purification). FDA's definition for product code NIH reads: "Disinfectant intended for reprocessing water purification systems for hemodialysis". FDA records list 46 510(k) clearances for Medivators, Inc., from to . As of , FDA records show no recalls naming K133724.

Clearance record

Decision date
Received
(264 days to decision)
Product code
NIH Disinfectant, Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medivators, Inc. 14605 28th Ave. N., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NIH

Trailing 12 months

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

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