510(k) · Cleared
ClearedRedsense Alarm System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Redsense Medical AB · ODX Autonomous Extracorporeal Blood Leak Detector/Alarm
Cleared on Nov 22, 2013 as substantially equivalent to K103242 (Redsense Medical AB, 2011) and 2 other predicates after a 263-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Nov 22, 2013
- Review
- 263 days
- Class
- Class II
- Product code
- ODX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K890824 (1989). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK890824 Fresenius 2008 Touch Panel Control Dialysis SystemFresenius USA, Inc. · 1989
- 3 generations backK071013 RedsenseRedsense Medical AB · 2007
- 2 generations backK092955 Redsense-Home UseRedsense Medical AB · 2010
- 1 generation backK103242 Redsense-Alarm Unit and SensorRedsense Medical AB · 2011
- This deviceK130554 Redsense Alarm SystemRedsense Medical AB · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890824 | Fresenius 2008 Touch Panel Control Dialysis System | Fresenius USA, Inc. | 1989 | — |
| −3 | K071013 | Redsense | Redsense Medical AB | 2007 | — |
| −2 | K092955 | Redsense-Home Use | Redsense Medical AB | 2010 | — |
| −1 | K103242 | Redsense-Alarm Unit and Sensor | Redsense Medical AB | 2011 | — |
| 0 (this device) | K130554 | Redsense Alarm System | Redsense Medical AB | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103242 | Redsense-Alarm Unit and SensorSummary page 1…rade name and Class ification: Redsense alarm system., Class 11, 21 CER 876.5820 and product code ODX Equivalent Device Identification: Redsense Medical alarm unit K103242 Redsense Medical home use K092955 Device Description: Redsense Medical provides a system for monitoring the blood access duri… | 2011 |
| * | K092955 | Redsense-Home UseSummary page 1…nse alarm system., Class 11, 21 CER 876.5820 and product code ODX Equivalent Device Identification: Redsense Medical alarm unit K103242 Redsense Medical home use K092955 Device Description: Redsense Medical provides a system for monitoring the blood access during haernodialysis consisting of an… | 2010 |
| * | K071013 | RedsenseSummary page 3…use) Type of Clinical trial No new clinical data. No new clinical data. No new clinical data. obtained Same as K<071013 Same as K071013 used. Same as K<071013 used. used. Electrical co… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All ODX devicesODX Autonomous Extracorporeal Blood Leak Detector/Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · ODX
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · ODX
Too few ODX 510(k)s in any year since 2007 to give a median.
Recalls per year · ODX
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODX
1in 2025
MAUDE reports naming product code ODX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device's sensor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130554 · printed Nov 3, 2026
Cite this page
510(k) Report. “K130554: Redsense Alarm System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K130554
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026