510(k) · Cleared
ClearedMedtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic PS Medical · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jan 26, 1999 as substantially equivalent to K954021 (Johnson & Johnson Professionals, Inc., 1995) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1992. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 26, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920156 (1992). 2 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK920156 Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYClinical Neuro Systems, LLC · 1992 · Recalled (Class I)
- This deviceK983799 Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical…Medtronic PS Medical · 1999
- Descendant · cites it directly · 0 of its ownK201118 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 SYdirect predicate · 1992
Most influential descendants
Showing 1 of 1 · See all- K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…Medtronic, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SY | Clinical Neuro Systems, LLC | 1992 | Class I |
| 0 (this device) | K983799 | Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau… | Medtronic PS Medical | 1999 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 13.0 · 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? (2)
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 |
|---|---|---|---|
| * | K954021 | External Drainage System (Eds and Eds II)Summary page 1…c PS Medical Niveau Drainage System m lor ificati . Intracranial Pressure Monitoring Devices (882.1620) Predicate Device Identification: Codman External Drainage System (K954021), Clinical Neuro Systems MoniTorr (K920156) Description: The reusable portion of the system is comprised of a pressure scale, m… | 1995 |
| * | K920156 | Clinical Neuro Syst Monitorr Ext CSF Drain/Moni SYSummary page 1…icati . Intracranial Pressure Monitoring Devices (882.1620) Predicate Device Identification: Codman External Drainage System (K954021), Clinical Neuro Systems MoniTorr (K920156) Description: The reusable portion of the system is comprised of a pressure scale, mounting clamp and optional laser level. All… | 1992 |
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 |
|---|---|---|---|
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta… | 2020 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
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. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with Severe head injury…
Read the full statement (107 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.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with
Severe head injury;
Subarachnoid hemorrhage graded Ill, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983799 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983799: Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983799
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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