Redsense Alarm System
by Redsense Medical AB Sweden 510(k)
510(k) K130554
Product code ODX
Overview
The Redsense Alarm System is an Autonomous Extracorporeal Blood Leak Detector/Alarm, designed to monitor blood access during hemodialysis procedures. It employs a non-invasive sensor patch and an alarm unit to detect extracorporeal blood leakage at venous needle access sites, ensuring patient safety by triggering an immediate audible alarm when leakage is detected. The system utilises infrared light technology to continuously assess the integrity of the blood access pathway, preventing complications associated with undetected leaks.
The device consists of an alarm unit, extension fiber, and a sensor patch, supplied as a complete set. It is intended for use in both clinical and home hemodialysis settings by trained personnel or patients under supervision. The system is powered by a wall outlet and is classified as a Class II medical device under FDA regulations. Authorised under FDA 510(k) clearance (K130554), it adheres to regulatory standards for extracorporeal blood monitoring in gastroenterology and urology applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130554 | Date22 Nov 2013 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ODX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
Redsense is an alarm system for monitoring the blood access during hemodialysis. The Redsense system consists of an alarm unit, an extension fiber and a non invasive sensor patch. When the sensor patch is placed over the blood access, it detects any blood coming in contact with the sensor.
Other devices from Redsense Medical AB
Questions
What is the Redsense Alarm System designed to do?
The Redsense Alarm System is an Autonomous Extracorporeal Blood Leak Detector/Alarm that continuously monitors blood access during hemodialysis. It uses infrared light technology in a non-invasive sensor patch to detect leaks at venous needle access sites, alerting users with an audible alarm to prevent complications from undetected blood loss.
How is the Redsense Alarm System supplied and what does it include?
The system is supplied as a complete set, including an alarm unit, extension fiber, and a sensor patch. This setup ensures all components are ready for immediate use in both clinical and home hemodialysis environments.
Is the Redsense Alarm System single-use or reusable?
The device is designed for single-use applications. While the alarm unit may be reusable across procedures, the sensor patch and extension fiber are intended for one-time use to maintain sterility and reliability.
How does the Redsense Alarm System ensure patient safety during hemodialysis?
The system employs infrared light technology to continuously assess the integrity of the blood access pathway. If a leak is detected at the venous needle access site, the device triggers an immediate audible alarm, allowing trained personnel or supervised patients to intervene promptly and prevent complications.
Where can the Redsense Alarm System be used, and who operates it?
The device is approved for use in both clinical hemodialysis centers and home hemodialysis settings. It is intended for operation by trained healthcare professionals or patients under direct supervision to ensure proper monitoring and response to alarms.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K130554