510(k) · Cleared
Recalled · 2012Codman Intracranial Bolt
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 Jan 9, 1998 after a 71-day review. The FDA summary names its predicate without a number. 34 later devices descend from it. It has been recalled once.
- Decided
- Jan 9, 1998
- Review
- 71 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 1
- Predicates
- 0
34 later devices descend from it, 3 citing it directly.
- This deviceK974088 Codman Intracranial BoltJohnson & Johnson Professionals, Inc. · 1998
- Descendant · cites it directly · 22 of its ownK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- Descendant · 2 generations on · 17 of its ownK050702 Neurosystems 1TM MonitorNeurosystems, LLC · 2005
- Descendant · 3 generations on · 15 of its ownK061640 Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006
- Descendant · 4 generations on · 14 of its ownK080217 Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · Recalled
- Descendant · cites it directly · 8 of its ownK062584 Pressio Icp Monitoring SystemSophysa SA · 2007 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K013930NeurosensorNovus Monitoring, Ltd. · 2002 · cites it directly22descendants
- K050702Neurosystems 1TM MonitorNeurosystems, LLC · 2005 · 2 generations on17descendants
- K061640Integra Mobius Multi-Modality Monitoring SystemIntegra LifeSciences Corporation · 2006 · 3 generations on15descendants
- K080217Component Neuromonitoring SystemMoberg Research, Inc. · 2008 · 4 generations on14descendants
- K062584Pressio Icp Monitoring SystemSophysa SA · 2007 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974088 | Codman Intracranial Bolt | Johnson & Johnson Professionals, Inc. | 1998 | — |
| +1 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| +2 | K050702 | Neurosystems 1TM Monitor | Neurosystems, LLC | 2005 | — |
| +3 | K061640 | Integra Mobius Multi-Modality Monitoring System | Integra LifeSciences Corporation | 2006 | — |
| +4 | K080217 | Component Neuromonitoring System | Moberg Research, Inc. | 2008 | 1 |
| +1 | K062584 | Pressio Icp Monitoring System | Sophysa SA | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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™ Skull Bolt Named without a submission number | |
| * | — | Camino ICP Bolt Named without a submission number |
What descends from it? (34)
See all 343 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2012 | Not classified | Z-1279-2012 | Nonconforming Material/Component | Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013930 (Novus Monitoring, Ltd., 2002) has gone furthest, with 22 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?
The CODMAN® Intracranial Bolt is indicated for use as a component of an intracranial pressure (ICP) monitoring system designed to achieve direct ICP monitoring. Specifically, the CODMAN® Intracranial Bolt is intended to secure an ICP transducer during direct ICP monitoring in both subdural and intraparenchymal 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/K974088 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974088: Codman Intracranial Bolt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974088
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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