# K071013: Redsense

- Pathway: 510(k) (Traditional)
- Applicant: Redsense Medical AB
- Decided: Oct 18, 2007 after 191 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: 1 generation back to K890824 (1989). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972314: Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System, Diametrics Medical, Ltd. (1997) Summary page 1.
- K890824: Fresenius 2008 Touch Panel Control Dialysis System, Fresenius USA, Inc. (1989) Summary page 1.

## Most influential descendants
- K092955: Redsense-Home Use (2010), 2 descendants of its own
- K103242: Redsense-Alarm Unit and Sensor (2011), 1 descendant of its own
- 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 hemodialysis patients undergoing continuous hemodialysis treatment up to 5 hours in the clinical setting. 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/K071013
Methodology: https://510kreport.com/methodology