510(k) · Cleared
ClearedMPS Oxiport and MPS Oxiport Plus
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 Apr 29, 2008 as substantially equivalent to K041838 (Innerspace, Inc., 2005) and 2 other predicates after a 249-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 29, 2008
- Review
- 249 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002765 (2000). 12 ancestors in all, the oldest K813459 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000 · Recalled
- 2 generations backK013005 Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002
- 1 generation backK041838 MPS (or MPS-T)Innerspace, Inc. · 2005
- This deviceK072379 MPS Oxiport and MPS Oxiport PlusInnerspace, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK083378 SynergyInnerspace, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK161010 HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… | Integra Neurosciences | 2000 | 3 |
| −2 | K013005 | Act 11 MP Ventricular Catheter | Innerspace, Inc. | 2002 | — |
| −1 | K041838 | MPS (or MPS-T) | Innerspace, Inc. | 2005 | — |
| 0 (this device) | K072379 | MPS Oxiport and MPS Oxiport Plus | Innerspace, Inc. | 2008 | — |
| +1 | K083378 | Synergy | Innerspace, Inc. | 2009 | — |
| +2 | K161010 | HICP200 Patient/Monitor Interconnect Cable | Innerspace Neuro Solutions, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (5)
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 |
|---|---|---|---|
| * | K041838 | MPS (or MPS-T)Summary page 1…RI compatible will have the words "MRI Conditional" under the device name Predicate Devices Predicate device related to Function and Design: K041838 - Concurrence date 03/01/2005 - Product code GWM: Device, Monitoring, Intracranial Pressure. The catheter uses… | 2005 |
| * | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/)Summary page 1…couple ICP to an external transducer. It provides two probe ports. Predicate device related to temperature sensing in a ventricular catheter K962928 - Camino. K041838 -InnerSpace. Predicate device related to the larger size of catheters used in trauma patients:… | 1996 |
| * | K003905 | Acti-Icp Monitoring SystemSummary page 1…cular catheters with an OD ranging from 7.5 to 11.5 Fr. Predicate device related to sensing pressure in parenchyma tissue K003905 -InnerSpace Modified Device 1 CSF drainaae An 8, 9 and 10 Fr. model will be added to the line. The user wi… | 2001 |
| * | — | Camino Named without a submission number | |
| * | — | Codman Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083378 | Synergy | 2009 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K083378 (Innerspace, Inc., 2009) has gone furthest, with 1 descendant 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. 2008, this device’s year, is highlighted.
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 Hummingbird HUMV-500 or HUMV-500MR 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, when data from one or more parameters may be deemed useful in providing optimum patient management and, in the case of the Hummingbird-500MR, when an MRI may be indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072379: MPS Oxiport and MPS Oxiport Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072379
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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