510(k) Report

510(k) · Cleared

Cleared

Duet External Drainage and Monitoring System (EDMS)

K242034510(k) SpecialCleared Oct 24, 2024105-day reviewClass II21 CFR 882.5560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Neurosurgery · PCB External Cerebrospinal Fluid (Csf) Diversion

Cleared on Oct 24, 2024 as substantially equivalent to DEN120017 (Medtronic Neurosurgery, 2014) after a 105-day review. Its family tree reaches back 1 generation to 2014.

Decided
Oct 24, 2024
Review
105 days
Class
Class II
Product code
PCB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN120017 (2014). No later device cites it as a predicate yet.

Reference device: K201118 · Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level · Medtronic, Inc. · 2020DEN120017 · Medtronic DUET External Drainage and Monitoring System · Medtronic Neurosurgery · 20142010201520202025
DEN120017 · Medtronic DUET External Drainage and Monitoring System · Medtronic Neurosurgery · 20140
  1. Root · 1 generation backDEN120017 Medtronic DUET External Drainage and Monitoring SystemMedtronic Neurosurgery · 2014
  2. This deviceK242034 Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN120017Medtronic DUET External Drainage and Monitoring SystemMedtronic Neurosurgery2014—
0 (this device)K242034Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery2024—
FIG. 1 — Lineage of K242034, 2014–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 PCB? 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN120017Medtronic DUET External Drainage and Monitoring System
Summary page 5
…Product Code: PCB Regulation: 21 CFR 882.5560 V. Identification of Legally Marketed Predicate Devices Primary Predicate device: Duet External Drainage and Monitoring (DEN120017) Reference device: Exacta External Drainage and Monitoring System (K201118) VI. Product Description The Medtronic Duet External…
Medtronic Neurosurgery2014—
†K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…Medtronic, Inc.2020—

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?

  • Its one ancestor has no recall.

How does its category compare?

All PCB devices

PCB External Cerebrospinal Fluid (Csf) Diversion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · PCB

1in 2024

2014: 12024: 1
2007high 1 (2014) · low 0 (2007)2026

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

2015: 32018: 32023: 82024: 122025: 1
2007high 12 (2024) · low 0 (2007)2025

MAUDE reports naming product code PCB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—03
20160—00
20170—00
20180—03
20190—00
20200—00
20210—00
20220—00
20230—08
20241—012
20250—01
20260—0—

What is it indicated for?

The DUET EDMS is 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.

2. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

Indications for use as stated in the FDA summary.

More from Medtronic Neurosurgery

28 FDA decisions under this applicant name. See the company

  • K243676Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2025
  • K212641StrataMR II Valves and ShuntsMedtronic Neurosurgery · 2021
  • K181622StrataMR guider toolMedtronic Neurosurgery · 2018
  • K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery · 20161 recall
  • K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 20161 Class I recall

Recent decisions in PCB

The PCB category page

  • DEN120017Medtronic DUET External Drainage and Monitoring SystemMedtronic Neurosurgery · 2014

https://510kreport.com/device/K242034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K242034: Duet External Drainage and Monitoring System (EDMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242034

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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