510(k) · Cleared
ClearedAct Iii 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 Sep 9, 2002 after a 305-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Sep 9, 2002
- Review
- 305 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK013705 Act Iii Ventricular CatheterInnerspace, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK041838 MPS (or MPS-T)Innerspace, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK072379 MPS Oxiport and MPS Oxiport PlusInnerspace, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK083378 SynergyInnerspace, Inc. · 2009
- Descendant · 4 generations on · 0 of its ownK161010 HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK113088 Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird…Innerspace, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K041838MPS (or MPS-T)Innerspace, Inc. · 2005 · cites it directly3descendants
- K072379MPS Oxiport and MPS Oxiport PlusInnerspace, Inc. · 2008 · 2 generations on2descendants
- K083378SynergyInnerspace, Inc. · 2009 · 3 generations on1descendant
- K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016 · 4 generations on0descendants
- K113088Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird Subdural- H800S (Icp Only)Innerspace, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013705 | Act Iii Ventricular Catheter | Innerspace, Inc. | 2002 | — |
| +1 | K041838 | MPS (or MPS-T) | Innerspace, Inc. | 2005 | — |
| +2 | K072379 | MPS Oxiport and MPS Oxiport Plus | Innerspace, Inc. | 2008 | — |
| +3 | K083378 | Synergy | Innerspace, Inc. | 2009 | — |
| +4 | K161010 | HICP200 Patient/Monitor Interconnect Cable | Innerspace Neuro Solutions, Inc. | 2016 | — |
| +1 | K113088 | Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird Subdural- H800S… | Innerspace, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 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? (1)
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 |
|---|---|---|---|
| * | — | Camino WNTRIXB True Tech Ventricular Tunneling Pressure Monitoring Kit NL960-V Named without a submission number |
What descends from it? (5)
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, K041838 (Innerspace, Inc., 2005) has gone furthest, with 3 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 use of a ACT 111 Ventricular Catheter by a qualified neurosurgeon is indicated when direct measurement of the intracranial pressure is clinically important and when the patient may require CSF drainage in the course of care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013705 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013705: Act Iii Ventricular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013705
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026