510(k) · Cleared
Recalled · Class II · 2025CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Nov 8, 2017 as substantially equivalent to K153347 (Codman & Shurtleff, Inc., 2016) after a 37-day review. Its family tree reaches back 2 generations to 1994. It has been recalled once.
- Decided
- Nov 8, 2017
- Review
- 37 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914479 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 1 generation backK153347 Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt…Codman & Shurtleff, Inc. · 2016 · Recalled
- This deviceK173192 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt…Codman & Shurtleff, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −1 | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit… | Codman & Shurtleff, Inc. | 2016 | 1 |
| 0 (this device) | K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit… | Codman & Shurtleff, Inc. | 2017 | — |
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 |
|---|---|---|---|
| * | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman…Summary page 4…GWM Rx or OTC Designation Rx Only III. Predicate The predicate device for this submission is the Codman Microsensor Kits Device (K153347), which was cleared on August 19, 2016. IV. Device The CereLink ICP Sensor Kits are used to monitor intracranial pressure… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2025 | Class II | Z-1037-2026 | Process control | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 22.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K153347.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
CereLink ICP Sensor Basic Kit (82-6850); CereLink ICP Sensor Metal Skull (82-6851); CereLink ICP Sensor Plastic Skull (82-6852)
Indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
CereLink ICP Sensor Ventricular Catheter Kit (82-6854)
Indicated when direct intraventricular pressure monitoring is required. The kit is indicated for use in ICP monitoring and cerebrospinal fluid (CSF) drainage applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173192: CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173192
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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