510(k) · Cleared
ClearedIntegra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino Flex Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifescience Corportation · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jul 20, 2012 as substantially equivalent to K904883 (Baxter Healthcare Corp, 1991) and 3 other predicates after a 95-day review. Its family tree reaches back 2 generations to 1982. 2 later devices descend from it.
- Decided
- Jul 20, 2012
- Review
- 95 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K813459 (1982). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
- 1 generation backK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
- This deviceK121159 Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit…Integra Lifescience Corportation · 2012
- Descendant · cites it directly · 0 of its ownK133754 Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit…Integra LifeSciences Corporation · 2014
- Descendant · cites it directly · 0 of its ownK131184 Integra Licox PTO2 MonitorIntegra Lifesciences Corp. · 2013 · Recalled
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 |
|---|---|---|---|---|---|
| −2 | K813459 | Reusable & Disposable Temp. Probes | Electromedics, Inc. | 1982 | — |
| −1 | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | Camino Neurocare, Inc. | 1996 | 2 |
| 0 (this device) | K121159 | Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with… | Integra Lifescience Corportation | 2012 | — |
| +1 | K133754 | Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex… | Integra LifeSciences Corporation | 2014 | — |
| +1 | K131184 | Integra Licox PTO2 Monitor | Integra Lifesciences Corp. | 2013 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K904883 | OPTYXSummary page 1…oring Kit device(s) to which (catalog number: NL950-V; formerly known as the OPTYX equivalence is claimed catheter) 5 10O(k) K904883 Codmane MicroSensor" Ventricular Catheter Kit 5 10O(k) K99 1222… | 1991 |
| * | K991222 | Codman Microsensor Ventricular Catheter KitSummary page 1…catheter) 5 10O(k) K904883 Codmane MicroSensor" Ventricular Catheter Kit 5 10O(k) K99 1222 Ventricular Pressure Monitoring Kit, Model I1O-4HM 5 10(k) -K914735… | 1999 |
| * | K914735 | Ventricular Pressure Monitoring Kit, Model 110-4HMSummary page 1…Kit 5 10O(k) K99 1222 Ventricular Pressure Monitoring Kit, Model I1O-4HM 5 10(k) -K914735 Combined Intracranial Pressure-Temperature Sensing System (with pre-am… | 1992 |
| * | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/)Summary page 1…Intracranial Pressure-Temperature Sensing System (with pre-amplification cable, catalog number PACl1) 5 10O(k) K962928 Reason for 5 10(k) New Device submission Integra LifeSciences Corporation-Traditional 5 10(k) IntegraTr… | 1996 |
What descends from it? (2)
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?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 15.6 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K133754 (Integra LifeSciences Corporation, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K904883.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Integra Camino® Flex Ventricular Intracranial Pressure Monitoring Kit with Integra Camino® Flex Adapter is indicated when direct and continuous intraventricular intracranial pressure (ICP) monitoring and cerebrospinal fluid (CSF) drainage are required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121159: Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino Flex Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121159
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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