510(k) · Cleared
ClearedHermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corp. · JXG Shunt, Central Nervous System And Components
Cleared on Feb 26, 2003 as substantially equivalent to K972994 (Integra Neurocare, LLC, 1997) after a 29-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Feb 26, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864676 (1986). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK864676 Heyer-Schulte Hermetic External CSF Drain. SystemAmerican V. Mueller · 1986
- 1 generation backK972994 External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997
- This deviceK030289 Hermetic Plus External CSF Drainage Systems…Integra Lifesciences Corp. · 2003
- Descendant · cites it directly · 1 of its ownK121248 Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF…Moller Medical GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK150898 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864676 | Heyer-Schulte Hermetic External CSF Drain. System | American V. Mueller | 1986 | — |
| −1 | K972994 | External CSF Drainage Management Systems | Integra Neurocare, LLC | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K972994 | External CSF Drainage Management SystemsSummary page 1…ion and intended use to the unmodified External CSF Drainage and Management Systems which has been cleared to market under Premarket Notification 5 10(k) K972994. Intended use: The Hermetic PlusTM External CSF Drainage System is indicated for draining and monitoring of cereb… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121248 | Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM)… | 2013 | 1 |
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 17 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K121248 (Moller Medical GmbH, 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K972994.
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 Hermetic Plu? External CSF Drainage System is indicated for draining and monitoring of
Cerebrospinal Fluid (CSF) flow from the lateral ventricles of the brain or lumbar subarachnoid space
in selected patients to reduce intracranial pressure (ICP), monitor intracranial pressure (ICP), monitor
cerebrospinal fluid (CSF), and provide temporary CSF drainage for patients with infected
hydrocephalic shunts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030289 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030289: Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030289
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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