510(k) · Cleared
ClearedIntellidrop
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainspace, Inc. · JXG Shunt, Central Nervous System And Components
Cleared on Dec 10, 2025 as substantially equivalent to K172759 (Aqueduct Critical Care, Inc., 2017) after a 197-day review. Its family tree reaches back 5 generations to 1990. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 10, 2025
- Review
- 197 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902257 (1990). 6 ancestors in all. No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK902257 Codman* External Drainage System II (Eds-II)Codman & Shurtleff, Inc. · 1990
- 4 generations backK984053 Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · Recalled (Class I)
- 3 generations backK161605 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2016
- 2 generations backK171586 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
- 1 generation backK172759 Smart External Drain (SED) SystemAqueduct Critical Care, Inc. · 2017
- This deviceK251598 IntellidropBrainspace, Inc. · 2025
Class I recalls in this family
- K984053 Becker External Drainage and Monitoring System2 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902257 | Codman* External Drainage System II (Eds-II) | Codman & Shurtleff, Inc. | 1990 | — |
| −4 | K984053 | Becker External Drainage and Monitoring System | Medtronic PS Medical | 1999 | Class I |
| −3 | K161605 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2016 | — |
| −2 | K171586 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017 | — |
| −1 | K172759 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | 2017 | — |
| 0 (this device) | K251598 | Intellidrop | Brainspace, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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.
1 device in this family has 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 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 |
|---|---|---|---|
| * | K172759 | Smart External Drain (SED) SystemSummary page 6…e and intracranial pressure (ICP) for ventricular or lumbar use. Predicate Device: • Smart External Drain (SED) System by Aqueduct Critical Care Inc. (K172759) The BrainSpace Intellidrop is substantially similar to the predicate. The intended use and patient populations are identical an… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K984053Becker External Drainage and Monitoring SystemMedtronic PS Medical · 1999 · 2 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K172759.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Intellidrop system is indicated for use to provide external drainage of cerebrospinal fluid (CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) for ventricular or lumbar use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251598 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251598: Intellidrop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251598
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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