510(k) · Cleared
ClearedDirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jan 22, 2016 as substantially equivalent to K945585 (Johnson & Johnson Professionals, Inc., 1995) after a 127-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 22, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945585 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945585 Coman (R) CU-11 Model Number 82-6634Johnson & Johnson Professionals, Inc. · 1995
- This deviceK152670 DirectLink ICP Module, DirectLink ICP Extension Cable, Patient…Medos International SARL · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945585 | Coman (R) CU-11 Model Number 82-6634 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| 0 (this device) | K152670 | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor… | Medos International SARL | 2016 | — |
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 |
|---|---|---|---|
| * | K945585 | Coman (R) CU-11 Model Number 82-6634Summary page 4…Device (21 CFR 882.1620) Regulatory Class II Product Code GWM III. Predicate Codman CU-II (ICP Express), K945585 Device IV. Device DirectLink ICP Module Description The DirectLink ICP Module is a direct interfac… | 1995 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K945585.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 intended use of the DirectLink Module is to enable the connection of Codman intracranial pressure sensors to an available invasive blood pressure input channel on select commercially available third party patient bedside monitor systems.
The DirectLink ICP Extension Cable is intended for use as a connecting cable between the DirectLink ICP Module and a Codman Microsensor ICP Transducer.
The Patient Monitor Interface Cable is intended for use as a connecting cable between DirectLink ICP Module, and selected patient monitors available from third party suppliers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152670: DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152670
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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