510(k) · Cleared
Recalled · Class I · 2023CereLink ICP Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Production Corporation · GWM Device, Monitoring, Intracranial Pressure
Cleared on Apr 30, 2021 as substantially equivalent to K183406 (Integra Lifesciences Corp., 2019) after a 28-day review. Its family tree reaches back 1 generation to 2019. 2 of the 3 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Apr 30, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K183406 (2019). 1 later device descends from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK183406 CereLink ICP Monitor, CereLink ICP Extension CableIntegra Lifesciences Corp. · 2019 · Recalled
- This deviceK210993 CereLink ICP MonitorIntegra Lifesciences Production Corporation · 2021
- Descendant · cites it directly · 0 of its ownK232890 CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation · 2024 · Recalled (Class I)
Class I recalls in this family
- K232890 CereLink ICP Monitor (826820), CereLink ICP…cites it directly · 2024
Most influential descendants
Showing 1 of 1 · See all- K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | Integra Lifesciences Corp. | 2019 | 1 |
| 0 (this device) | K210993 | CereLink ICP Monitor | Integra Lifesciences Production Corporation | 2021 | — |
| +1 | K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Integra Lifesciences Production Corporation | 2024 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K183406 | CereLink ICP Monitor, CereLink ICP Extension CableSummary page 4…I Product Code OWM Rx or OTC Designation Rx Only (3) Predicate Information Predicate Device CereLink ICP Monitor: K183406 Reference Device Codman ICP Express: K945585 (4) Device Description The CereLink ICP Monitor is indicated for… | 2019 |
| † | K945585 | Coman (R) CU-11 Model Number 82-6634 | 1995 |
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 |
|---|---|---|---|
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) Class I | 2024 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 5, 2023 | Class I | Z-0548-2024 | Device Design | Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to address the "out of… |
| Jun 22, 2022 | Class I | Z-1395-2022 | Device Design | Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K232890 (Integra Lifesciences Production Corporation, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210993: CereLink ICP Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210993
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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