510(k) · Cleared
Recalled · Class II · 2009Aesculap Spiegelberg Brain Pressure Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jun 28, 2001 as substantially equivalent to K962928 (Camino Neurocare, Inc., 1996) after a 204-day review. Its family tree reaches back 2 generations to 1982. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 28, 2001
- Review
- 204 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K813459 (1982). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK813459 Reusable & Disposable Temp. ProbesElectromedics, Inc. · 1982
- 1 generation backK962928 Combined Intracranial Pressure-Temperature Sensing System (Icp/)Camino Neurocare, Inc. · 1996 · Recalled
- This deviceK003759 Aesculap Spiegelberg Brain Pressure MonitorAesculap, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK161010 HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161010HICP200 Patient/Monitor Interconnect CableInnerspace Neuro Solutions, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813459 | Reusable & Disposable Temp. Probes | Electromedics, Inc. | 1982 | — |
| −1 | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | Camino Neurocare, Inc. | 1996 | 2 |
| 0 (this device) | K003759 | Aesculap Spiegelberg Brain Pressure Monitor | Aesculap, Inc. | 2001 | — |
| +1 | K161010 | HICP200 Patient/Monitor Interconnect Cable | Innerspace Neuro Solutions, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/)Summary page 2…mendments Device (legally marketed comparison device): AESCULAP® Inc. believes that the Codman Intracranial Pressure Monitor (991222) and the Integra NeuroCare, Camino (K962928) devices are substantially equivalent.. A basic feature comparison table for the Aesculap® - Spiegelberg Brain Pressure Monitorin… | 1996 |
| * | — | Codman Intracranial Pressure Monitor (991222) Named without a submission number |
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 |
|---|---|---|---|
| K161010 | HICP200 Patient/Monitor Interconnect Cable | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2009 | Class II | Z-2888-2016 | Packaging | In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K161010 (Innerspace Neuro Solutions, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K962928.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Aesculap® - Spiegelberg Brain Pressure Monitoring System is indicated for use in those conditions where continuous monitoring of intracranial pressure is required. As dictated by clinical judgment, direct measurement of intracranial pressure (ICP) may be obtained from subdural, parenchymal or intraventricular probe locations.
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/K003759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003759: Aesculap Spiegelberg Brain Pressure Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003759
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026