510(k) Report

FDA applicant

Ewc

Pewaukee, WI2 decisions1998–19990 recalls

FDA records 2 decisions for Ewc (Pewaukee, WI) from 1998 to 1999: 2 510(k) clearances. All are in product code DSA (Cable, Transducer And Electrode, Patient…). Its devices cite 6 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Ewc since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ewc 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?

  • DSACable, Transducer And Electrode, Patient, (Including Connector)2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K984263Ewc: Ecg II Cable Leadwire SystemEwc · 1999
  • K982817Ewc: Ecg Cable and Leadwire SystemsEwc · 1998

All 2 as Ewc →