510(k) Report

FDA applicant

Ysis, Inc.

Yellow Springs, OH2 decisions1991–19920 recalls

FDA records 2 decisions for Ysis, Inc. (Yellow Springs, OH) from 1991 to 1992: 2 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and EZL (Catheter, Retention Type, Balloon). 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, clinical chemistry panel, where it files most

How often FDA has decided Ysis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ysis, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ysis, Inc. 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?

  • CGAGlucose Oxidase, Glucose1decision
  • EZLCatheter, Retention Type, Balloon1decision

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.

  • K913806Ysi Model 2300 Stat PlusYsis, Inc. · 19912cite it

What has FDA decided for it lately?

  • K921561Ysi Models 4400 Foley Catheter Temperature ProbesYsis, Inc. · 1992
  • K913806Ysi Model 2300 Stat PlusYsis, Inc. · 1991

All 2 as Ysis, Inc. →