510(k) · Cleared
ClearedCamino Single Parameter Monitor, Model SPM-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences · GWM Device, Monitoring, Intracranial Pressure
Cleared on May 14, 2003 as substantially equivalent to K962928 (Camino Neurocare, Inc., 1996) after a 37-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- May 14, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813459 (1982). 6 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK031086 Camino Single Parameter Monitor, Model SPM-1Integra Neurosciences · 2003
View 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) | K031086 | Camino Single Parameter Monitor, Model SPM-1 | Integra Neurosciences | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 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 |
|---|---|---|---|
| * | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/)Summary page 1…e Parameter Monitor, Model SPM - 1 b. Unmodified: CaminoB Multi-Parameter Monitor Model MPM- 1, cleared 12/20/96 under 5 1O(k) K962928 Common Name: Intracranial Pressure Monitor Classification Name: Intracranial Pressure Monitoring Device… | 1996 |
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 21 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 8 other devices also cite its predicate K962928.
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 Camino SPM-1 Intracranial Pressure Monitor is indicated for use when direct measurement of intracranial pressure (ICP) is clinically important.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031086: Camino Single Parameter Monitor, Model SPM-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031086
Report an extraction error
Are you the manufacturer?
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