510(k) · Cleared
ClearedAct 11 MP Ventricular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innerspace, Inc. · HCA Catheter, Ventricular
Cleared on Mar 8, 2002 as substantially equivalent to K010422 (Innerspace, Inc., 2001) and 1 other predicate after a 183-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Mar 8, 2002
- Review
- 183 days
- Class
- Class II
- Product code
- HCA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002765 (2000). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000 · Recalled
- This deviceK013005 Act 11 MP 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
Most influential descendants
Showing 4 of 4 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… | Integra Neurosciences | 2000 | 3 |
| 0 (this device) | K013005 | Act 11 MP 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 HCA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K010422 | Act II Icp Monitoring System and Ventricular CatheterSummary page 1…673 2293 South Pullman Street, Suite A Santa Ana, CA. 92705 Contact: Donald E. Bobo ext 12 Prepared Sept. 4, 2001 This submittal covers a modification to ACT II, 510(k) K010422. The modification adds the ability to insert a monitoring probe through the device and into the brain via a guide tube. The probe… | 2001 |
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 1…It simply guides an inserted probe to a point above the dura. The cap and guide tube are similar in function to the introducer kits described in predicate device 510(k) K002765- by Licox. The rest of the device is similar in function and features as predicate device 510(k) K010422 - ACT Il by InnerSpace… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041838 | MPS (or MPS-T) | 2005 | 3 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K041838 (Innerspace, Inc., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HCA devicesHCA Catheter, Ventricular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCA
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · HCA
Too few HCA 510(k)s in any year since 2007 to give a median.
Recalls per year · HCA
No recall names HCA since 2007.
Adverse event reports per year · HCA
1in 2021
MAUDE reports naming product code HCA, 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 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The use of the ACT II MP Monitoring System by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in parenchyma is clinically important and when the patient may require CSF drainage in the course of their care or when data from a second parameter may be deemed useful in optimum patient management.
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/K013005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013005: Act 11 MP Ventricular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013005
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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