510(k) · Cleared
ClearedLiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moller Medical GmbH · JXG Shunt, Central Nervous System And Components
Cleared on Dec 18, 2015 as substantially equivalent to K121248 (Moller Medical GmbH, 2013) after a 260-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Dec 18, 2015
- Review
- 260 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864676 (1986). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK864676 Heyer-Schulte Hermetic External CSF Drain. SystemAmerican V. Mueller · 1986
- 3 generations backK972994 External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997
- 2 generations backK030289 Hermetic Plus External CSF Drainage Systems…Integra Lifesciences Corp. · 2003
- 1 generation backK121248 Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF…Moller Medical GmbH · 2013
- This deviceK150898 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864676 | Heyer-Schulte Hermetic External CSF Drain. System | American V. Mueller | 1986 | — |
| −3 | K972994 | External CSF Drainage Management Systems | Integra Neurocare, LLC | 1997 | — |
| −2 | K030289 | Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700… | Integra Lifesciences Corp. | 2003 | — |
| −1 | K121248 | Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set… | Moller Medical GmbH | 2013 | — |
| 0 (this device) | K150898 | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm | Moller Medical GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (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 |
|---|---|---|---|
| * | K121248 | Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM)…Summary page 4…sign, operating principles, materials, CSF pressure monitoring, semiconductor sensor principle, display, alarm functions and data recording. LiquoGuard CSF System: K121248 4. Device Description Cerebrospinal fluid (CSF) drainage and pressure monitoring in lumbar and ventricular applications is the… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 4 companies; a new generation was cleared every 10.8 years on median.
- 4 of the 11 ancestors have a recall of any class.
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. 2015, 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 LiquoGuard 7 is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intrathecal pressure. The LiquoGuard 7 controls CSF pressure using pressure sensors and a pump and also monitors CSF pressure and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150898 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150898: LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150898
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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