510(k) Report

FDA applicant

Oximetrix, Inc.

Mchenry, IL12 decisions1976–19862 recalls

FDA records 12 decisions for Oximetrix, Inc. (Mchenry, IL) from 1976 to 1986: 12 510(k) clearances. Most are in product codes DQE (Catheter, Oximeter, Fiber-Optic) and GEI (Electrosurgical, Cutting & Coagulation &…). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Oximetrix, Inc. since 2007.

Recalls per year

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

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