510(k) · Cleared
ClearedCodman Microsensor Ventricular Catheter Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jul 9, 1999 after an 88-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.
- Decided
- Jul 9, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK991222 Codman Microsensor Ventricular Catheter KitJohnson & Johnson Professionals, Inc. · 1999
- Descendant · cites it directly · 8 of its ownK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
- Descendant · 2 generations on · 7 of its ownK103206 Raumedic- Icp-Monitoring SystemRaumedic AG · 2011
- Descendant · 2 generations on · 6 of its ownK112017 Raumedic Icp Monitoring SystemRaumedic AG · 2011
- Descendant · 3 generations on · 5 of its ownK120252 Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012
- Descendant · 3 generations on · 4 of its ownK130529 Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K062584Pressio Icp Monitoring SystemSophysa SA · 2007 · cites it directly8descendants
- K103206Raumedic- Icp-Monitoring SystemRaumedic AG · 2011 · 2 generations on7descendants
- K112017Raumedic Icp Monitoring SystemRaumedic AG · 2011 · 2 generations on6descendants
- K120252Raumedic-Icp-Temp-Monitoring-SystemRaumedic AG · 2012 · 3 generations on5descendants
- K130529Raumedic-Pto-Monitoring-SystemRaumedic AG · 2013 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991222 | Codman Microsensor Ventricular Catheter Kit | Johnson & Johnson Professionals, Inc. | 1999 | — |
| +1 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
| +2 | K103206 | Raumedic- Icp-Monitoring System | Raumedic AG | 2011 | — |
| +2 | K112017 | Raumedic Icp Monitoring System | Raumedic AG | 2011 | — |
| +3 | K120252 | Raumedic-Icp-Temp-Monitoring-System | Raumedic AG | 2012 | — |
| +3 | K130529 | Raumedic-Pto-Monitoring-System | Raumedic AG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 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 |
|---|---|---|---|
| * | — | CODMAN® MICROSENSOR™ Catheter Kit Named without a submission number | |
| * | — | CAMINO NeuroCare™, Inc. Ventrix™ Ventricular Tunneling Pressure Monitoring Kit Named without a submission number |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K062584 (Sophysa SA, 2007) has gone furthest, with 8 descendants of its own.
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?
Use of the CODMAN® MICROSENSOR™ Ventricular Catheter Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in intraventricular pressure monitoring and cerebrospinal fluid (CSF) drainage applications.
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/K991222 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991222: Codman Microsensor Ventricular Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991222
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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