510(k) · Cleared
ClearedDuet External Drainage and Monitoring System (EDMS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neurosurgery · JXG Shunt, Central Nervous System And Components
Cleared on Mar 10, 2025 as substantially equivalent to K200456 (Medtronic, Inc., 2020) after a 103-day review. Its family tree reaches back 3 generations to 1990. 2 of the 5 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 10, 2025
- Review
- 103 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902257 (1990). 4 ancestors in all. No later device cites it as a predicate yet. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- 2 generations backK984053 Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · Recalled (Class I)
- 1 generation backK200456 Becker External Drainage and Monitoring SystemMedtronic, Inc. · 2020 · Recalled (Class I)
- This deviceK243676 Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902257 | Codman* External Drainage System II (Eds-II) | Codman & Shurtleff, Inc. | 1990 | — |
| −2 | K984053 | Becker External Drainage and Monitoring System | Medtronic PS Medical | 1999 | Class I |
| −1 | K200456 | Becker External Drainage and Monitoring System | Medtronic, Inc. | 2020 | Class I |
| 0 (this device) | K243676 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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.
2 devices in this family have a Class I recall. 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K200456 | Becker External Drainage and Monitoring SystemSummary page 5…lassification Product Code: JXG V. Identification of Legally Marketed Predicate and Reference Devices Predicate device: Becker External Drainage and Monitoring System (K200456) Reference device: Duet™ External Drainage and Monitoring System (K242034) VI. Product Description The Medtronic Duet™ External… | 2020 |
| † | K242034 | Duet External Drainage and Monitoring System (EDMS) | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K200456Becker External Drainage and Monitoring SystemMedtronic, Inc. · 2020 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K984053Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
- 2 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Duet EDMS is indicated for draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to: • Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative. • Monitor CSF chemistry, cytology, and physiology. • Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: • Severe head…
Read the full statement (116 words)
The Duet EDMS is indicated for draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to:
• Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative.
• Monitor CSF chemistry, cytology, and physiology.
• Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
• Severe head injury
• Subarachnoid hemorrhage graded III, IV, or V preoperatively
• Reyes syndrome or similar encephalopathies
• Hydrocephalus
• Intracranial hemorrhage
• Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243676: Duet External Drainage and Monitoring System (EDMS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243676
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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