510(k) · Cleared
ClearedIntegra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · GWM Device, Monitoring, Intracranial Pressure
Cleared on Mar 6, 2014 as substantially equivalent to K121159 (Integra Lifescience Corportation, 2012) after an 87-day review. Its family tree reaches back 3 generations to 1982.
- Decided
- Mar 6, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K813459 (1982). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
- 2 generations backK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
- 1 generation backK121159 Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit…Integra Lifescience Corportation · 2012
- This deviceK133754 Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit…Integra LifeSciences Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813459 | Reusable & Disposable Temp. Probes | Electromedics, Inc. | 1982 | — |
| −2 | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | Camino Neurocare, Inc. | 1996 | 2 |
| −1 | K121159 | Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with… | Integra Lifescience Corportation | 2012 | — |
| 0 (this device) | K133754 | Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Flex… | Integra LifeSciences Corporation | 2014 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K121159 | Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with Intrgra Camino…Summary page 1…- Legally marketed device(s) to which equivalence is claimed Integra'"M Caminoo Flex Ventricular Intracranial Pressure Monitoring Kit with Integra' Camino® Flex Adapter K 121 159 807.92(a)(4) - Device description The Integra" Caminoo Flex Ventricular Intracranial Pressure Monitoring Kit functions as an enti… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 4 companies; a new generation was cleared every 14.7 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K121159.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Use of the lntegrTM Camino® Flex Ventricular Intracranial Pressure Monitoring Kit 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/K133754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133754: Integra Camino Flex Ventricular Intracranial Pressure Monitoring Kit with 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/K133754
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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