510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K941867Substantially Equivalent

Renalin Reuse Cart

Renal Scientific Service, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941867 is the FDA 510(k) clearance record for RENALIN REUSE CART, a class II device, cleared for Renal Scientific Service, Inc. on under FDA product code LIF (Dialyzer Reprocessing System). FDA records list one 510(k) clearance for Renal Scientific Service, Inc. As of , FDA records show no recalls naming K941867.

Clearance record

Decision date
Received
(644 days to decision)
Product code
LIF Dialyzer Reprocessing System
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Renal Scientific Service, Inc. Reservior Pl., Waltham MA
510(k) summary
Statement
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