510(k) · Cleared
ClearedSynergy
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 29, 2009 as substantially equivalent to K072379 (Innerspace, Inc., 2008) after a 319-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Sep 29, 2009
- Review
- 319 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002765 (2000). 13 ancestors in all, the oldest K813459 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002765 Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB…Integra Neurosciences · 2000 · Recalled
- 3 generations backK013005 Act 11 MP Ventricular CatheterInnerspace, Inc. · 2002
- 2 generations backK041838 MPS (or MPS-T)Innerspace, Inc. · 2005
- 1 generation backK072379 MPS Oxiport and MPS Oxiport PlusInnerspace, Inc. · 2008
- This deviceK083378 SynergyInnerspace, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK161010 HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc… | Integra Neurosciences | 2000 | 3 |
| −3 | K013005 | Act 11 MP Ventricular Catheter | Innerspace, Inc. | 2002 | — |
| −2 | K041838 | MPS (or MPS-T) | Innerspace, Inc. | 2005 | — |
| −1 | K072379 | MPS Oxiport and MPS Oxiport Plus | Innerspace, Inc. | 2008 | — |
| 0 (this device) | K083378 | Synergy | Innerspace, Inc. | 2009 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072379 | MPS Oxiport and MPS Oxiport PlusSummary page 1…Approved 510OK Device Name: MPS Oxiport and MPS Oxiport Plus New Device Names: Trilogy Predicate Device Predicate device: K072379 MPS Oxiport Plus. Summary This submittal covers a device that allows the placement of a ventricular catheter and… | 2008 |
| † | K003905 | Acti-Icp Monitoring System | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161010 | HICP200 Patient/Monitor Interconnect Cable | 2016 | 0 |
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 9 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K161010 (Innerspace Neuro Solutions, Inc., 2016) has gone furthest, with 0 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. 2009, 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 Trilogy system 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 one or more parameters may be deemed useful in providing optimum patient management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083378 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083378: Synergy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083378
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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