510(k) Report

FDA applicant

Darox Corp.

Niles, IL2 decisions1989–19891 recall

FDA records 2 decisions for Darox Corp. (Niles, IL) in 1989: 2 510(k) clearances. All are in product code DRO (Pacemaker, Cardiac, External Transcutaneous…). 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Darox Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Darox Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2decisions

What has FDA decided for it lately?

  • K895729R2 Pace Pad, Model 480Darox Corp. · 19891 recall
  • K895728R2 Pace Adaptor Cable, Model 196Darox Corp. · 1989

All 2 as Darox Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K895729Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction…May 18, 2006