510(k) · Cleared
ClearedMPS (or MPS-T)
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 Mar 1, 2005 as substantially equivalent to K013005 (Innerspace, Inc., 2002) and 2 other predicates after a 237-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Mar 1, 2005
- Review
- 237 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002765 (2000). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000 · Recalled
- 1 generation backK013005 Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002
- This deviceK041838 MPS (or MPS-T)Innerspace, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK072379 MPS Oxiport and MPS Oxiport PlusInnerspace, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK083378 SynergyInnerspace, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK161010 HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… | Integra Neurosciences | 2000 | 3 |
| −1 | K013005 | Act 11 MP Ventricular Catheter | Innerspace, Inc. | 2002 | — |
| 0 (this device) | K041838 | MPS (or MPS-T) | Innerspace, Inc. | 2005 | — |
| +1 | K072379 | MPS Oxiport and MPS Oxiport Plus | Innerspace, Inc. | 2008 | — |
| +2 | K083378 | Synergy | Innerspace, Inc. | 2009 | — |
| +3 | 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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (3)
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 |
|---|---|---|---|
| * | K013005 | Act 11 MP Ventricular CatheterSummary page 1…CFR 882.4100 (84HCA 2.4 Equivalent device The bolt system is substantially equivalent to ACT IIMP plus coveted in 510-K 013005. The 005 device is a bolt that can receive the ventricular catheter of ACT II (705) and hold a second parameter p… | 2002 |
| * | K013705 | Act Iii Ventricular CatheterSummary page 1…r catheter of ACT II (705) and hold a second parameter probe. The pressure sensing system used is the same as that used in ACT IJR. It is covered in 510-K 013705 (705). The drainage catheter system is similar to that used in 705 except the catheter size is smaller. The MIP… | 2002 |
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 1…e MIPS- OXIPORT bolt guide tubes are similar to that described in ACT II MN(005). The guide tubes are substantially equivalent to guide tubes described in Licox (002765) as regards having the tubes extend beyond the dura - 2.5 Description of the Catheter's ICP Mon… | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072379 | MPS Oxiport and MPS Oxiport Plus | 2008 | 2 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K072379 (Innerspace, Inc., 2008) has gone furthest, with 2 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 MPS (or MPS-T) by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure is clinically important, when the patient may require CSF drainage in the course of their care and when data from a second or third parameter may be deemed useful in optimum patient management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041838: MPS (or MPS-T).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041838
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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