510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K850799Substantially Equivalent

Rinse Machine Kr-4 Kidney Rinse-4

Medical Technologies International, Inc., Flint Mi MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850799 is the FDA 510(k) clearance record for RINSE MACHINE KR-4 KIDNEY RINSE-4, a class II device, cleared for Medical Technologies International, Inc. on under FDA product code LIF (Dialyzer Reprocessing System). FDA records list 3 510(k) clearances for Medical Technologies International, Inc., from to . As of , FDA records show no recalls naming K850799.

Clearance record

Decision date
Received
(152 days to decision)
Product code
LIF Dialyzer Reprocessing System
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Medical Technologies International, Inc. 3922 N. Sagihaw St., Flint Mi MI
Third party review
No

Clearances, product code LIF

Trailing 12 months

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

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