# K902783: PS Medical Delta CSF-Flow Control Valve

- Pathway: 510(k) (Traditional)
- Applicant: Pudenz-Schulte Medical Research Corp.
- Decided: Aug 8, 1990 after 43 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
39 later devices descend from it; 4 cite it directly.
1 of 40 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
- K992173: Siphonguard CSF Control Device (2000), 9 descendants of its own
- K020667: Codman Hakim Shunt Systems (2002), 8 descendants of its own

## Recalls of this device
- 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
- Dec 16, 2020 · Class II · Z-0871-2021: Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter wh
- Dec 16, 2020 · Class II · Z-0872-2021: Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter wh
- Dec 16, 2020 · Class II · Z-0873-2021: Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter wh
- Nov 18, 2013 · Class II · Z-0398-2014: Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Source page: https://510kreport.com/device/K902783
Methodology: https://510kreport.com/methodology