510(k) · Cleared
Recalled · Class I · 2024Becker External Drainage and Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Mar 26, 2020 as substantially equivalent to K984053 (Medtronic PS Medical, 1999) after a 30-day review. Its family tree reaches back 2 generations to 1990. 2 of the 5 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Mar 26, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902257 (1990). 3 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- 1 generation backK984053 Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · Recalled (Class I)
- This deviceK200456 Becker External Drainage and Monitoring SystemMedtronic, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK243676 Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2025
Class I recalls in this family
- K984053 Becker External Drainage and Monitoring Systemdirect predicate · 1999
Most influential descendants
Showing 1 of 1 · See all- K243676Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902257 | Codman* External Drainage System II (Eds-II) | Codman & Shurtleff, Inc. | 1990 | — |
| −1 | K984053 | Becker External Drainage and Monitoring System | Medtronic PS Medical | 1999 | Class I |
| 0 (this device) | K200456 | Becker External Drainage and Monitoring System | Medtronic, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 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 |
|---|---|---|---|
| * | K984053 | Becker External Drainage and Monitoring SystemSummary page 6…Subject Device Predicate Device K984053 Intended use / Draining and monitoring of CSF flow Draining and monitoring of CSF flow from Indications for from the… | 1999 |
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 |
|---|---|---|---|
| K243676 | Duet External Drainage and Monitoring System (EDMS) | 2025 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2024 | Class I | Z-0661-2025 | Under Investigation by firm | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| Nov 1, 2024 | Class I | Z-0662-2025 | Under Investigation by firm | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
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.
- K984053Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · Direct predicate · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 21.1 years on median.
- 1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K243676 (Medtronic Neurosurgery, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K984053.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, 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 | 2 | — | 0 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: 1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative; 2. Monitor CSF chemistry, cytology, and physiology; 3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: 1. Severe head injury 2.…
Read the full statement (112 words)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative;
2. Monitor CSF chemistry, cytology, and physiology;
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
1. Severe head injury
2. Subarachnoid hemorrhage graded III, IV, or V preoperatively
3. Reyes syndrome or similar encephalopathies
4. Hydrocephalus
5. Intracranial hemorrhage
6. 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/K200456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200456: Becker External Drainage and Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200456
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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