510(k) · Cleared
Recalled · Class II · 2021PS Medical Bioglide CSF-Flow Control Shunt Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pudenz-Schulte Medical Research Corp. · JXG Shunt, Central Nervous System And Components
Cleared on Sep 18, 1995 after a 181-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 28 devices in its family, counting itself, has a Class I recall. 27 later devices descend from it. It has been recalled 31 times.
- Decided
- Sep 18, 1995
- Review
- 181 days
- Class
- Class II
- Product code
- JXG
- Recalls
- 31
- Predicates
- 0
27 later devices descend from it, 3 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- This deviceK951258 PS Medical Bioglide CSF-Flow Control Shunt KitPudenz-Schulte Medical Research Corp. · 1995
- Descendant · cites it directly · 25 of its ownK012052 Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002
- Descendant · 2 generations on · 23 of its ownK033850 Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and…Medtronic Neurosurgery · 2004 · Recalled
- Descendant · 2 generations on · 19 of its ownK042465 PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · Recalled
- Descendant · 2 generations on · 7 of its ownK060681 Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · Recalled
- Descendant · 3 generations on · 6 of its ownK062009 Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
1998high 3 (2004) · low 0 (1999)2026
Class I recalls in this family
- K152700 StrataMR Valves and Shunts3 generations on · 2016
Most influential descendants
Showing 5 of 27 · See all- K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855Medtronic PS Medical · 2002 · cites it directly25descendants
- K033850Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without BioglideMedtronic Neurosurgery · 2004 · 2 generations on23descendants
- K042465PS Medical Strata II ValveMedtronic Neurosurgery · 2004 · 2 generations on19descendants
- K060681Medtronic PS Medical Strata Type ValueMedtronic Neurosurgery · 2006 · 2 generations on7descendants
- K062009Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451TAesculap, Inc. · 2007 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951258 | PS Medical Bioglide CSF-Flow Control Shunt Kit | Pudenz-Schulte Medical Research Corp. | 1995 | — |
| +1 | K012052 | Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 | Medtronic PS Medical | 2002 | — |
| +2 | K033850 | Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without… | Medtronic Neurosurgery | 2004 | 2 |
| +2 | K042465 | PS Medical Strata II Valve | Medtronic Neurosurgery | 2004 | 4 |
| +2 | K060681 | Medtronic PS Medical Strata Type Value | Medtronic Neurosurgery | 2006 | 2 |
| +3 | K062009 | Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T | Aesculap, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (27)
See all 273 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2021 | Class II | Z-1117-2021 | Process control | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus |
| Jan 11, 2021 | Class II | Z-1115-2021 | Process control | Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus |
| Feb 12, 2009 | Not classified | Z-1148-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1127-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1146-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1145-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1139-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1124-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1137-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1152-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1138-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1125-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1130-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1131-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1126-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1135-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1147-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1134-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1140-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1151-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1143-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1133-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1142-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1132-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1141-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1149-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1136-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1144-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1128-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1129-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
| Feb 12, 2009 | Not classified | Z-1150-2009 | Device Design | The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery. |
The 5 latest of 31 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152700StrataMR Valves and ShuntsMedtronic Neurosurgery · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K012052 (Medtronic PS Medical, 2002) has gone furthest, with 25 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
2007high 8 (2025) · low 0 (2014)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
2007high 276 (2015) · low 30 (2010)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
2007high 30 (2009) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
2007high 1,484 (2018) · low 629 (2009)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 | — |
https://510kreport.com/device/K951258 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951258: PS Medical Bioglide CSF-Flow Control Shunt Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951258
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026