510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K875312Substantially Equivalent

Ufr Digital Retrofit

Yankee Intl. Medical Research & Mfg., Ltd., Manchese NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875312 is the FDA 510(k) clearance record for UFR DIGITAL RETROFIT, a class II device, cleared for Yankee Intl. Medical Research & Mfg., Ltd. on under FDA product code FJB (Detector, Dialysate Level). FDA records list one 510(k) clearance for Yankee Intl. Medical Research & Mfg., Ltd. As of , FDA records show no recalls naming K875312.

Clearance record

Decision date
Received
(52 days to decision)
Product code
FJB Detector, Dialysate Level
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Yankee Intl. Medical Research & Mfg., Ltd. P.O. Box 151, Manchese NH
Third party review
No

Clearances, product code FJB

Trailing 12 months

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

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