510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K092955Substantially Equivalent

Redsense-Home Use

Redsense Medical AB, Fridley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092955 is the FDA 510(k) clearance record for REDSENSE-HOME USE, a class II device, cleared for Redsense Medical AB on under FDA product code ODX (Autonomous Extracorporeal Blood Leak Detector/Alarm). FDA's definition for product code ODX reads: "To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to...". FDA records list 4 510(k) clearances for Redsense Medical AB, from to . As of , FDA records show no recalls naming K092955.

Clearance record

Decision date
Received
(227 days to decision)
Product code
ODX Autonomous Extracorporeal Blood Leak Detector/Alarm
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Redsense Medical AB 435 Rice Creek Terrance, Fridley MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODX

Trailing 12 months

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

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