510(k) · Cleared
ClearedAct II Icp Monitoring System and Ventricular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innerspace, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jun 28, 2001 after a 136-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 28, 2001
- Review
- 136 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK010422 Act II Icp Monitoring System and Ventricular CatheterInnerspace, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK013005 Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK041838 MPS (or MPS-T)Innerspace, Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK072379 MPS Oxiport and MPS Oxiport PlusInnerspace, Inc. · 2008
- Descendant · 4 generations on · 1 of its ownK083378 SynergyInnerspace, Inc. · 2009
- Descendant · 5 generations on · 0 of its ownK161010 HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K013005Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002 · cites it directly4descendants
- K041838MPS (or MPS-T)Innerspace, Inc. · 2005 · 2 generations on3descendants
- K072379MPS Oxiport and MPS Oxiport PlusInnerspace, Inc. · 2008 · 3 generations on2descendants
- K083378SynergyInnerspace, Inc. · 2009 · 4 generations on1descendant
- K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010422 | Act II Icp Monitoring System and Ventricular Catheter | Innerspace, Inc. | 2001 | — |
| +1 | K013005 | Act 11 MP Ventricular Catheter | Innerspace, Inc. | 2002 | — |
| +2 | K041838 | MPS (or MPS-T) | Innerspace, Inc. | 2005 | — |
| +3 | K072379 | MPS Oxiport and MPS Oxiport Plus | Innerspace, Inc. | 2008 | — |
| +4 | K083378 | Synergy | Innerspace, Inc. | 2009 | — |
| +5 | K161010 | HICP200 Patient/Monitor Interconnect Cable | Innerspace Neuro Solutions, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013005 | Act 11 MP Ventricular Catheter | 2002 | 4 |
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, K013005 (Innerspace, Inc., 2002) has gone furthest, with 4 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/K010422 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010422: Act II Icp Monitoring System and Ventricular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010422
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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