FDA applicant

Rondex Products, Inc.

Rockford, IL11 decisions1984–19980 recalls

FDA records 11 decisions for Rondex Products, Inc. (Rockford, IL) from 1984 to 1998: 11 510(k) clearances. Most are in product codes CBP (Valve, Non-Rebreathing) and BTM (Ventilator, Emergency, Manual (Resuscitator)). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Rondex Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Rondex Products, Inc.

Which product codes does it file in?

What has FDA decided for it lately?