510(k) Report

FDA applicant

Lgch, Inc.

San Antonio, TX1 decision2017–20170 recalls

FDA records 1 decision for Lgch, Inc. (San Antonio, TX) in 2017: 1 De Novo grant. All are in product code POS (Physiological Signal Based Seizure Monitoring…). No recall is 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 Lgch, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Lgch, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • POSPhysiological Signal Based Seizure Monitoring System1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

What has FDA decided for it lately?

The one decision as Lgch, Inc. →