510(k) · Cleared
ClearedComan (R) CU-11 Model Number 82-6634
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 Oct 26, 1995 after a 346-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Oct 26, 1995
- Review
- 346 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK945585 Coman (R) CU-11 Model Number 82-6634Johnson & Johnson Professionals, Inc. · 1995
- 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 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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) | K945585 | Coman (R) CU-11 Model Number 82-6634 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| +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 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
2 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 | — |
https://510kreport.com/device/K945585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945585: Coman (R) CU-11 Model Number 82-6634.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945585
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026