510(k) · Cleared
ClearedRedsense-Alarm Unit and Sensor
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 Feb 10, 2011 as substantially equivalent to K071013 (Redsense Medical AB, 2007) and 2 other predicates after a 100-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Feb 10, 2011
- Review
- 100 days
- Class
- Class II
- Product code
- ODX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K890824 (1989). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK890824 Fresenius 2008 Touch Panel Control Dialysis SystemFresenius USA, Inc. · 1989
- 2 generations backK071013 RedsenseRedsense Medical AB · 2007
- 1 generation backK092955 Redsense-Home UseRedsense Medical AB · 2010
- This deviceK103242 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 1 of 1 · See all- K130554Redsense Alarm SystemRedsense Medical AB · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890824 | Fresenius 2008 Touch Panel Control Dialysis System | Fresenius USA, Inc. | 1989 | — |
| −2 | K071013 | Redsense | Redsense Medical AB | 2007 | — |
| −1 | K092955 | Redsense-Home Use | Redsense Medical AB | 2010 | — |
| 0 (this device) | 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 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K071013 | RedsenseSummary page 1…11, 876.5820, 876.5540, product code ODX Submission Purpose: Expand Intended Use for up to 8 hours clinical use. Equivalent Device Identification: Redsense Medical AB K071013 Redsense Medical AB K092955 Gamnbro, Inc K070643 Device Description: Redsense is a system for monitoring the vein needle during… | 2007 |
| * | K092955 | Redsense-Home UseSummary page 1…duct code ODX Submission Purpose: Expand Intended Use for up to 8 hours clinical use. Equivalent Device Identification: Redsense Medical AB K071013 Redsense Medical AB K092955 Gamnbro, Inc K070643 Device Description: Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consi… | 2010 |
| * | K070643 | Phoenix Hemodialysis Delivery System, Version 3.35Summary page 1…sion Purpose: Expand Intended Use for up to 8 hours clinical use. Equivalent Device Identification: Redsense Medical AB K071013 Redsense Medical AB K092955 Gamnbro, Inc K070643 Device Description: Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consists of an alarm unit… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130554 | Redsense Alarm System | 2013 | 0 |
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 22 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K130554 (Redsense Medical AB, 2013) has gone furthest, with 0 descendants 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. 2011, 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 heniodialysis patients undergoing continuous hemnodialysis treatment up to 8 hours in the clinical settings. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103242: Redsense-Alarm Unit and Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103242
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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