# K951258: PS Medical Bioglide CSF-Flow Control Shunt Kit

- Pathway: 510(k) (Traditional)
- Applicant: Pudenz-Schulte Medical Research Corp.
- Decided: Sep 18, 1995 after 181 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 3 cite it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 (2002), 25 descendants of its own
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide (2004), 23 descendants of its own
- K042465: PS Medical Strata II Valve (2004), 19 descendants of its own
- K060681: Medtronic PS Medical Strata Type Value (2006), 7 descendants of its own
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T (2007), 6 descendants of its own

## Recalls of this device
- Jan 11, 2021 · Class II · Z-1117-2021: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Source page: https://510kreport.com/device/K951258
Methodology: https://510kreport.com/methodology