510(k) · Cleared
ClearedB4C System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braincare Desenvolvimento E Inovacao Tecnologica S.A. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Oct 8, 2021 as substantially equivalent to K182073 (Braincare Desenvolvimento E Inovacao Tecnologica S.A., 2019) after a 448-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Oct 8, 2021
- Review
- 448 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K914479 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK914479 Microsensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. · 1994 · Recalled
- 2 generations backK153347 Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt…Codman & Shurtleff, Inc. · 2016 · Recalled
- 1 generation backK182073 BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2019
- This deviceK201989 B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2021
- Descendant · cites it directly · 0 of its ownK240821 B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914479 | Microsensor Intracranial Pressure Transducer | Codman & Shurtleff, Inc. | 1994 | 3 |
| −2 | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit… | Codman & Shurtleff, Inc. | 2016 | 1 |
| −1 | K182073 | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019 | — |
| 0 (this device) | K201989 | B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021 | — |
| +1 | K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K182073 | BcSs-PICNI-2000 SensorSummary page 4…pressure monitoring device Regulatory Class: II Regulation: 21 CFR 882.1620 Product Code: GWM Predicate Device(s): BcSs-PICNI-2000 Sensor K182073 Device Description The B4C System is a non-invasive device intended for the monitoring of variation in intracranial pressure, i… | 2019 |
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 |
|---|---|---|---|
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | 2024 | 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 27 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K240821 (Braincare Desenvolvimento E Inovação Tecnológica S.A., 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 B4C System is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in intracranial compliance, by providing surrogate ICP waveforms and associated parameters (estimated P2/P1 ratio, normalized Time-to-Peak, derived useful ICP pulses and cardiac pulses) for interpretation.
Refer to device labeling for more information regarding the derivation and interpretation of the output of the device.
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/K201989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201989: B4C System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201989
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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