510(k) · Cleared
Recalled · Class II · 2025Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor 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 Aug 19, 2016 as substantially equivalent to K914479 (Codman & Shurtleff, Inc., 1994) after a 273-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it. It has been recalled once.
- Decided
- Aug 19, 2016
- Review
- 273 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914479 (1994). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- This deviceK153347 Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt…Codman & Shurtleff, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK182073 BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2019
- Descendant · 2 generations on · 1 of its ownK201989 B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2021
- Descendant · cites it directly · 0 of its ownK250285 Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R…Raumedic AG · 2025
- Descendant · 3 generations on · 0 of its ownK240821 B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A. · 2024
- Descendant · cites it directly · 0 of its ownK173192 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt…Codman & Shurtleff, Inc. · 2017 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K182073BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2019 · cites it directly2descendants
- K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2021 · 2 generations on1descendant
- K250285Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R (095317-003)…Raumedic AG · 2025 · cites it directly0descendants
- K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A. · 2024 · 3 generations on0descendants
- K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…Codman & Shurtleff, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| 0 (this device) | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit… | Codman & Shurtleff, Inc. | 2016 | — |
| +1 | K182073 | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019 | — |
| +2 | K201989 | B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021 | — |
| +1 | K250285 | Neurovent-P (092946-003); Neurovent (092956-003); Neurovent-Ifd-R… | Raumedic AG | 2025 | — |
| +3 | K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024 | — |
| +1 | K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit… | Codman & Shurtleff, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K914479 | Microsensor Intracranial Pressure TransducerSummary page 4…roduct Code: GWM Type of 510(k) Submission: Traditional 510(k) Basis for Submission: MR Labeling and Material Changes Predicate Device(s): K914479 Codman® Intracranial Pressure Transducer K974088 Codman® Intracranial Bolt (reference dev… | 1994 |
| † | K974088 | Codman Intracranial Bolt | 1998 |
| † | K991222 | Codman Microsensor Ventricular Catheter Kit | 1999 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1036-2026 | 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?
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?
62-6631 Codman Microsensor Basic Kit: Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only. 62-6632 and 62-6638 Codman Microsensor Skull Bolt Kit (Plastic and Metal): Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is…
Read the full statement (124 words)
62-6631 Codman Microsensor Basic Kit:
Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
62-6632 and 62-6638 Codman Microsensor Skull Bolt Kit (Plastic and Metal):
Use of the CODMAN MICROSENSOR Plastic/Metal Skull Bolt Kit is indicated when direct intracranial pressure (ICP) monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications.
62-6633 Codman Microsensor Catheter Kit and
62-6653 Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter:
Use of the Ventricular Catheter Kit is 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/K153347 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153347: Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153347
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