510(k) · Cleared
ClearedLevel Sensor, Level Sensor Tape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Cleared on May 8, 2015 as substantially equivalent to K070286 (Medtronic, 2007) and 1 other predicate after a 67-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- May 8, 2015
- Review
- 67 days
- Class
- Class II
- Product code
- DTW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K915183 (1992). 14 ancestors in all, the oldest K871131 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK915183 Sarns 8000 Modular Perfusion System3M Health Care, Sarns · 1992 · Recalled
- 4 generations backK953901 Sarns 800 Roller Pump3M Health Care, Sarns · 1996
- 3 generations backK022947 Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System…Terumo Cardiovascular Systems Corp. · 2003 · Recalled
- 2 generations backK052555 Medtronic Performer TM CPB, Model R51, PCPBRand S.R.L. · 2006 · Recalled
- 1 generation backK070213 Performer CBP SystemRand S.R.L. · 2007 · Recalled
- This deviceK150530 Level Sensor, Level Sensor TapeMedtronic, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915183 | Sarns 8000 Modular Perfusion System | 3M Health Care, Sarns | 1992 | 45 |
| −4 | K953901 | Sarns 800 Roller Pump | 3M Health Care, Sarns | 1996 | — |
| −3 | K022947 | Advanced Perfusion System 1 (100/120 Volt),Advanced Perfusion System 1… | Terumo Cardiovascular Systems Corp. | 2003 | 150 |
| −2 | K052555 | Medtronic Performer TM CPB, Model R51, PCPB | Rand S.R.L. | 2006 | 1 |
| −1 | K070213 | Performer CBP System | Rand S.R.L. | 2007 | 1 |
| 0 (this device) | K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2005 | 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 DTW? 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? (2)
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 |
|---|---|---|---|
| * | K070286 | Bio-Console, Model 560Summary page 5…Console 560 System Medtronic Performer CPB System Predicate 510(k): K070286, K070213 Device Description Level Sensing System includes the Level Sensor (LS100) and the Le… | 2007 |
| * | K070213 | Performer CBP SystemSummary page 5…560 System Medtronic Performer CPB System Predicate 510(k): K070286, K070213 Device Description Level Sensing System includes the Level Sensor (LS100) and the Level Senso… | 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 23 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 7 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K070286.
How does its category compare?
All DTW devicesDTW Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DTW
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTW
Too few DTW 510(k)s in any year since 2007 to give a median.
Recalls per year · DTW
5in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTW
4in 2024
MAUDE reports naming product code DTW, 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 | 0 | — | 5 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 20 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 47 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medtronic Bio-Console 560 System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
The Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]) is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150530 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150530: Level Sensor, Level Sensor Tape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150530
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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