# K092955: Redsense-Home Use

- Pathway: 510(k) (Traditional)
- Applicant: Redsense Medical AB
- Decided: May 10, 2010 after 227 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: 2 generations back to K890824 (1989). 3 ancestors in all.
2 later devices descend from it; 2 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)
- K071013: Redsense, Redsense Medical AB (2007) Summary page 1.

## Most influential descendants
- 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 hemodialysis treatment up to 5 hours at home or in the clinical setting. The device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected. All use must be administrated under physician's prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.

Source page: https://510kreport.com/device/K092955
Methodology: https://510kreport.com/methodology