510(k) Report

FDA applicant

P-S Medical

Walker, MI1 decision1984–19842 recalls

FDA records 1 decision for P-S Medical (Walker, MI) in 1984: 1 510(k) clearance. All are in product code JXG (Shunt, Central Nervous System And Components). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided P-S Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for P-S Medical since 2007.

Recalls per year

1in 2021

2013: 12021: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — P-S Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K841442P-S Medical CSF-Flow Control Valve-P-S Medical · 19841cites it

What has FDA decided for it lately?

  • K841442P-S Medical CSF-Flow Control Valve-P-S Medical · 19842 recalls

The one decision as P-S Medical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K792007Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following…Jan 11, 2021Class II
  • K792005CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized…Nov 18, 2013Class II