De Novo · Granted
GrantedMedtronic DUET External Drainage and Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · PCB External Cerebrospinal Fluid (Csf) Diversion
Granted on Aug 22, 2014 as a new device type through De Novo after a 609-day review. 1 later device descends from it.
- Decided
- Aug 22, 2014
- Review
- 609 days
- Class
- Class II
- Product code
- PCB
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN120017 Medtronic DUET External Drainage and Monitoring SystemMedtronic Neurosurgery · 2014
- Descendant · cites it directly · 0 of its ownK242034 Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2024
Most influential descendants
Showing 1 of 1 · See all- K242034Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN120017 | Medtronic DUET External Drainage and Monitoring System | Medtronic Neurosurgery | 2014 | — |
| +1 | K242034 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA De Novo 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 PCB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PCB device
- #1 K242034 Duet External Drainage and Monitoring System…score 8.2 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K242034 | Duet External Drainage and Monitoring System (EDMS) | 2024 | 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?
- Of its descendants, K242034 (Medtronic Neurosurgery, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PCB devicesPCB External Cerebrospinal Fluid (Csf) Diversion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PCB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PCB
Too few PCB 510(k)s in any year since 2007 to give a median.
Recalls per year · PCB
No recall names PCB since 2007.
Adverse event reports per year · PCB
1in 2025
MAUDE reports naming product code PCB, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Temporary draining and monitoring of cerebrospinal fluid (CSF) flow from the lumbar subarachnoid space in 1) patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery, and 2) patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN120017 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN120017: Medtronic DUET External Drainage and Monitoring System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN120017
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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