# K130554: Redsense Alarm System

- Pathway: 510(k) (Traditional)
- Applicant: Redsense Medical AB
- Decided: Nov 22, 2013 after 263 days
- Product code: ODX (Autonomous Extracorporeal Blood Leak Detector/Alarm)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890824 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103242: Redsense-Alarm Unit and Sensor, Redsense Medical AB (2011) Summary page 1.
- K092955: Redsense-Home Use, Redsense Medical AB (2010) Summary page 1.
- K071013: Redsense, Redsense Medical AB (2007) Summary page 3.

## Indications for use
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device's sensor.

Source page: https://510kreport.com/device/K130554
Methodology: https://510kreport.com/methodology