510(k) · Cleared
Recalled · Class II · 2016External Drainage Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Neurosciences Implants S.A. · JXG Shunt, Central Nervous System And Components
Cleared on Oct 6, 2003 as substantially equivalent to K910853 (Cordis Corp., 1991) after a 26-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910853 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910853 Graduated Cylinder of External Drainage SetCordis Corp. · 1991 · Recalled
- This deviceK032817 External Drainage SetIntegra Neurosciences Implants S.A. · 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 |
|---|---|---|---|---|---|
| −1 | K910853 | Graduated Cylinder of External Drainage Set | Cordis Corp. | 1991 | 1 |
| 0 (this device) | K032817 | External Drainage Set | Integra Neurosciences Implants S.A. | 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 | — |
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 |
|---|---|---|---|
| * | K910853 | Graduated Cylinder of External Drainage SetSummary page 1…ly equivalent in function and intended use to the Unmodified External Drainage Set which has been cleared to market under Preniarket Notification 5 10(k) K910853. D- I Integra NeuroSciences Implants S.A. Special 5 10(k): Device… | 1991 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 23, 2016 | Class II | Z-2910-2016 | Process control | During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K121248 (Moller Medical GmbH, 2013) has gone furthest, with 1 descendant 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 drainage sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032817: External Drainage Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032817
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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