510(k) · Cleared
ClearedBcSs-PICNI-2000 Sensor
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 17, 2019 as substantially equivalent to K153347 (Codman & Shurtleff, Inc., 2016) after a 442-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 17, 2019
- Review
- 442 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914479 (1994). 2 later devices descend from it, 1 citing it directly.
- 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 deviceK182073 BcSs-PICNI-2000 SensorBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2019
- Descendant · cites it directly · 1 of its ownK201989 B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A. · 2021
- Descendant · 2 generations on · 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 2 of 2 · See allView 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) | K182073 | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019 | — |
| +1 | K201989 | B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021 | — |
| +2 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman…Summary page 4…ssure monitoring device Regulatory Class: II Regulation: 882.1620 Product Code: GWM Predicate Device: Codman® Microsensor Basic Kit K153347 Reference Device: BrainPulse, Model 1100 DEN140040 Device Description The BcSs-PICNI-2000 Sensor (“the Braincare Sensor”… | 2016 |
| † | DEN140040 | Nautilus BrainPulse 1000 | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201989 | B4C System | 2021 | 1 |
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 25 years and passes through 2 companies; a new generation was cleared every 22.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K201989 (Braincare Desenvolvimento E Inovacao Tecnologica S.A., 2021) has gone furthest, with 1 descendant of its own.
- 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. 2019, 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 BcSs-PICNI-2000 Sensor is intended for the monitoring of variation in intracranial pressure in patients with suspected alteration of intracranial pressure (ICP) or change in brain compliance, by providing ICP waveforms for interpretation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182073: BcSs-PICNI-2000 Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182073
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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