510(k) · Cleared
ClearedExacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
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 May 26, 2020 as substantially equivalent to K983799 (Medtronic PS Medical, 1999) after a 29-day review. Its family tree reaches back 2 generations to 1992. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- May 26, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920156 (1992). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · Recalled (Class I)
- 1 generation backK983799 Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical…Medtronic PS Medical · 1999
- This deviceK201118 Exacta External Drainage and Monitoring System, Exacta Pole with…Medtronic, Inc. · 2020
Class I recalls in this family
- K920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY2 generations back · 1992
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY | Clinical Neuro Systems, LLC | 1992 | Class I |
| −1 | K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau… | Medtronic PS Medical | 1999 | — |
| 0 (this device) | K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level… | Medtronic, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System…Summary page 5…use as the predicate laser level. The rest of the Exacta EDMS device has the same technological characteristics as the predicate device. Subject Device Predicate Device K983799 Intended Draining and monitoring of CSF flow from | Same use/Indications the lateral ventricles or lumbar for Use subarachnoid s… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K920156Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 21.3 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I 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 and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to: 1. Reduce 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 ICP is indicated in selected patients with: 1. Severe head injury. 2. Subarachnoid hemorrhage graded III, IV or V…
Read the full statement (108 words)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:
1. Reduce 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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201118 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201118: Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201118
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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