510(k) · Cleared
ClearedCamino Slim-Line Intracranial Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novus Monitoring, Ltd. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Oct 22, 2004 as substantially equivalent to K013930 (Novus Monitoring, Ltd., 2002) and 2 other predicates after a 21-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it.
- Decided
- Oct 22, 2004
- Review
- 21 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K875179 (1988). 9 ancestors in all, the oldest K853864 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK875179 Modified Laserflo Blood Perfusion Monitor, BPM403ATsi, Inc. · 1988
- 3 generations backK951832 Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434…Vasamedics, LLC · 1996
- 2 generations backK961368 Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
- 1 generation backK013930 NeurosensorNovus Monitoring, Ltd. · 2002
- This deviceK042728 Camino Slim-Line Intracranial Monitoring SystemNovus Monitoring, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK172209 Aura Icp Monitoring SystemBranchpoint Technologies, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K172209Aura Icp Monitoring SystemBranchpoint Technologies, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875179 | Modified Laserflo Blood Perfusion Monitor, BPM403A | Tsi, Inc. | 1988 | — |
| −3 | K951832 | Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 | Vasamedics, LLC | 1996 | — |
| −2 | K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe Kit | Vasamedics, LLC | 1996 | — |
| −1 | K013930 | Neurosensor | Novus Monitoring, Ltd. | 2002 | — |
| 0 (this device) | K042728 | Camino Slim-Line Intracranial Monitoring System | Novus Monitoring, Ltd. | 2004 | — |
| +1 | K172209 | Aura Icp Monitoring System | Branchpoint Technologies, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K013930 | NeurosensorSummary page 1…Predicate Devices The components of the Camino Slim-LineTm system are substantially equivalent to the following legally marketed devices: K013930 NeuroSensorTM System K914479 Codman ICP monitoring system and MicrosensorTM ICP… | 2002 |
| * | K914479 | Microsensor Intracranial Pressure TransducerSummary page 1…mino Slim-LineTm system are substantially equivalent to the following legally marketed devices: K013930 NeuroSensorTM System K914479 Codman ICP monitoring system and MicrosensorTM ICP transducer 1K853864… | 1994 |
| * | K853864 | Intracranial Pressure Monitoring Kit 070Summary page 1…NeuroSensorTM System K914479 Codman ICP monitoring system and MicrosensorTM ICP transducer 1K853864 Camino Intracranial Pressure Monitoring Kit This statement is based on the subject device's similarity to the pred… | 1986 |
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 |
|---|---|---|---|
| K172209 | Aura Icp Monitoring System | 2018 | 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 16 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K172209 (Branchpoint Technologies, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013930.
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 Slim-LineTM Intracranial Monitoring System has been designed for use by a qualified neurosurgeon in the direct monitoring of intracranial pressure in both sub-dural and intraparenchymal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042728 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042728: Camino Slim-Line Intracranial Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042728
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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