510(k) · Cleared
ClearedExternal CSF Drainage Management Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurocare, LLC · JXG Shunt, Central Nervous System And Components
Cleared on Nov 3, 1997 as substantially equivalent to K932769 (Camino Laboratories, Inc., 1995) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it.
- Decided
- Nov 3, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864676 (1986). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK864676 Heyer-Schulte Hermetic External CSF Drain. SystemAmerican V. Mueller · 1986
- This deviceK972994 External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997
- Descendant · cites it directly · 2 of its ownK030289 Hermetic Plus External CSF Drainage Systems…Integra Lifesciences Corp. · 2003
- Descendant · 2 generations on · 1 of its ownK121248 Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF…Moller Medical GmbH · 2013
- Descendant · cites it directly · 0 of its ownK170599 SureFlo EVD CatheterArkis Biosciences, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK150898 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015
- Descendant · cites it directly · 0 of its ownK022638 Neurorecovery Ventricular Catheter & Main Valve Assembly KitNeurorecovery, Inc. · 2002
Most influential descendants
Showing 5 of 5 · See all- K030289Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830NIntegra Lifesciences Corp. · 2003 · cites it directly2descendants
- K121248Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM)…Moller Medical GmbH · 2013 · 2 generations on1descendant
- K170599SureFlo EVD CatheterArkis Biosciences, Inc. · 2017 · cites it directly0descendants
- K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015 · 3 generations on0descendants
- K022638Neurorecovery Ventricular Catheter & Main Valve Assembly KitNeurorecovery, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864676 | Heyer-Schulte Hermetic External CSF Drain. System | American V. Mueller | 1986 | — |
| 0 (this device) | K972994 | External CSF Drainage Management Systems | Integra Neurocare, LLC | 1997 | — |
| +1 | K030289 | Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700… | Integra Lifesciences Corp. | 2003 | — |
| +2 | K121248 | Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set… | Moller Medical GmbH | 2013 | — |
| +1 | K170599 | SureFlo EVD Catheter | Arkis Biosciences, Inc. | 2017 | 1 |
| +3 | K150898 | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm | Moller Medical GmbH | 2015 | — |
| +1 | K022638 | Neurorecovery Ventricular Catheter & Main Valve Assembly Kit | Neurorecovery, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 JXG? 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? (4)
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 |
|---|---|---|---|
| * | K932769 | Camino Ventricular Drainage SystemSummary page 1…ed products; the P-S Medical Becker External Drainage and Monitoring System, the Codman External Drainage System I, the Heyer-Schulte/Camino Ventricular Drainage System (K932769) and the Heyer-Schulte Hermetic External CSF Drainage System (K864676A) with respect to functionality, design, placement and use.… | 1995 |
| * | K864676 | Heyer-Schulte Hermetic External CSF Drain. SystemSummary page 1…on years of clinical history with external drainage systems manufactured from the same materials beginning with the Heyer-Schulte Hermetic External CSF Drainage System (K864676A), which was approved by FDA for market in 1982. The Heyer-Schulte NeuroCare External CSF Drainage Management Systems are substa… | 1986 |
| * | — | P-S Medical Becker External Drainage and Monitoring System Named without a submission number | |
| * | — | Codman External Drainage System I Named without a submission number |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K030289 (Integra Lifesciences Corp., 2003) has gone furthest, with 2 descendants of its own.
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.
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 major indication for use of the External CSF Drainage Management Systems is the management of hydrocephalic shunt infections.
If an internal shunt is not indicated, treatment of other cerebral conditions such as pre-operative drainage, intraventricular hemorrhage and post-operative pressure monitoring may also require external drainage to control increased intracranial pressure.
This device should only be used by a physician or qualified personnel under the direction of a physician.
Care must be taken to ensure compliance with the manufacturer's instructions for use.
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/K972994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972994: External CSF Drainage Management Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972994
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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