510(k) · Cleared
ClearedRedsense-Home Use
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 May 10, 2010 as substantially equivalent to K071013 (Redsense Medical AB, 2007) after a 227-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it.
- Decided
- May 10, 2010
- Review
- 227 days
- Class
- Class II
- Product code
- ODX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890824 (1989). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK890824 Fresenius 2008 Touch Panel Control Dialysis SystemFresenius USA, Inc. · 1989
- 1 generation backK071013 RedsenseRedsense Medical AB · 2007
- This deviceK092955 Redsense-Home UseRedsense Medical AB · 2010
- Descendant · cites it directly · 1 of its ownK103242 Redsense-Alarm Unit and SensorRedsense Medical AB · 2011
- Descendant · cites it directly · 0 of its ownK130554 Redsense Alarm SystemRedsense Medical AB · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890824 | Fresenius 2008 Touch Panel Control Dialysis System | Fresenius USA, Inc. | 1989 | — |
| −1 | K071013 | Redsense | Redsense Medical AB | 2007 | — |
| 0 (this device) | K092955 | Redsense-Home Use | Redsense Medical AB | 2010 | — |
| +1 | K103242 | Redsense-Alarm Unit and Sensor | Redsense Medical AB | 2011 | — |
| +1 | K130554 | Redsense Alarm System | Redsense Medical AB | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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? (1)
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 |
|---|---|---|---|
| * | K071013 | RedsenseSummary page 1…urpose: Expand Intended Use to Home Use. The device is equivalent to the Redsense device previously cleared. Equivalent Device Identification: Redsnse edicl A K071013 Device Description: Redsense Home Use is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consi… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 2 companies; a new generation was cleared every 18.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103242 (Redsense Medical AB, 2011) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071013.
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. 2010, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092955: Redsense-Home Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092955
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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