510(k) · Cleared
ClearedLiquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac
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 13, 2013 as substantially equivalent to K030289 (Integra Lifesciences Corp., 2003) and 2 other predicates after a 597-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it.
- Decided
- Dec 13, 2013
- Review
- 597 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K864676 (1986). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK864676 Heyer-Schulte Hermetic External CSF Drain. SystemAmerican V. Mueller · 1986
- 2 generations backK972994 External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997
- 1 generation backK030289 Hermetic Plus External CSF Drainage Systems…Integra Lifesciences Corp. · 2003
- This deviceK121248 Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF…Moller Medical GmbH · 2013
- Descendant · cites it directly · 0 of its ownK150898 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015
Most influential descendants
Showing 1 of 1 · See all- K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864676 | Heyer-Schulte Hermetic External CSF Drain. System | American V. Mueller | 1986 | — |
| −2 | 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 | — |
| 0 (this device) | K121248 | Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set… | Moller Medical GmbH | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K030289 | Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830NSummary page 2…quivalent to the 9SF drainage systems listed below with regard to intended use, design, operating principles, and materials. Integra NeuroSciences Corporation K030289, K03281 7 Codman & Shurtleff, Inc. K061568 The Mdller Medical LiquoGuard CSF System shares features with, the… | 2003 |
| * | K032817 | External Drainage SetSummary page 2…to the 9SF drainage systems listed below with regard to intended use, design, operating principles, and materials. Integra NeuroSciences Corporation K030289, K03281 7 Codman & Shurtleff, Inc. K061568 The Mdller Medical LiquoGuard CSF System shares features with, the intracran… | 2003 |
| * | K061568 | Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733…Summary page 2…to intended use, design, operating principles, and materials. Integra NeuroSciences Corporation K030289, K03281 7 Codman & Shurtleff, Inc. K061568 The Mdller Medical LiquoGuard CSF System shares features with, the intracranial pressure monitor listed below (the shared feature… | 2006 |
| † | K962928 | Combined Intracranial Pressure-Temperature Sensing System (Icp/) | 1996 |
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 |
|---|---|---|---|
| K150898 | LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm | 2015 | 0 |
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 27 years and passes through 4 companies; a new generation was cleared every 10.8 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K150898 (Moller Medical GmbH, 2015) has gone furthest, with 0 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. 2013, 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 CSF system 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 intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF…
Read the full statement (112 words)
The LiquoGuard CSF system 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 intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiquoGuard CSF system also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121248: Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM) Safety Cushion for Tubing Set Attac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121248
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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