# K103242: Redsense-Alarm Unit and Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Redsense Medical AB
- Decided: Feb 10, 2011 after 100 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: 3 generations back to K890824 (1989). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071013: Redsense, Redsense Medical AB (2007) Summary page 1.
- K092955: Redsense-Home Use, Redsense Medical AB (2010) Summary page 1.
- K070643: Phoenix Hemodialysis Delivery System, Version 3.35, Gambro, Inc. (2007) Summary page 1.

## Most influential descendants
- K130554: Redsense Alarm System (2013), 0 descendants of its own

## Indications for use
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in heniodialysis patients undergoing continuous hemnodialysis treatment up to 8 hours in the clinical settings. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.

Source page: https://510kreport.com/device/K103242
Methodology: https://510kreport.com/methodology