# Redsense Medical AB

- Location (FDA's records): Fridley, MN
- FDA decisions: 4 (2007–2013): 4 510(k) clearances
- Product codes: ODX (4)
- Predicates its devices cite: 9 (6 its own); citations of its devices by later devices: 6 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gambro, Inc.: 1 (https://510kreport.com/company/gambro)
- Diametrics Medical, Inc.: 1 (https://510kreport.com/company/diametrics-medical)
- Fresenius USA, Inc.: 1 (https://510kreport.com/company/fresenius-usa)

## Its most-cited devices
- K071013: Redsense (2007), cited by 3
- K092955: Redsense-Home Use (2010), cited by 2
- K103242: Redsense-Alarm Unit and Sensor (2011), cited by 1

## Recent decisions
- K130554: Redsense Alarm System (Nov 22, 2013)
- K103242: Redsense-Alarm Unit and Sensor (Feb 10, 2011)
- K092955: Redsense-Home Use (May 10, 2010)
- K071013: Redsense (Oct 18, 2007)

Source page: https://510kreport.com/company/redsense-medical