510(k) · Cleared
ClearedMedtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
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 Apr 9, 2020 as substantially equivalent to K802100 (Pudenz-Schulte Medical Research Corp., 1980) after a 30-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Apr 9, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K802100 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK802100 Intracranial Pressuring Monitoring Syst.Pudenz-Schulte Medical Research Corp. · 1980
- This deviceK200630 Medtronic External Drainage and Monitoring System, Medtronic…Medtronic, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K802100 | Intracranial Pressuring Monitoring Syst. | Pudenz-Schulte Medical Research Corp. | 1980 | — |
| 0 (this device) | K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage… | Medtronic, Inc. | 2020 | — |
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 GWM? 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 |
|---|---|---|---|
| * | K802100 | Intracranial Pressuring Monitoring Syst.Summary page 5…Subject Device Predicate Device K802100 Intended Draining CSF and monitoring CSF flow The monitoring of intracranial pressure use/Indications… | 1980 |
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 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 CSF and monitoring 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. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with: 1. Severe head injury…
Read the full statement (114 words)
Draining CSF and monitoring 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.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:
1. Severe head injury
2. Subarachnoid hemorrhage graded III, IV or V preoperatively
3. Reye’s 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 postoperative for space-occupying lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200630 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200630: Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200630
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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