510(k) Report

FDA applicant

Healthware Corp.

Durham, NC1 decision1988–19880 recalls

FDA records 1 decision for Healthware Corp. (Durham, NC) in 1988: 1 510(k) clearance. All are in product code NDC (Calculator, Drug Dose). 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 Healthware Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Healthware Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • NDCCalculator, Drug Dose1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K882001Diacare Monitoring SystemHealthware Corp. · 19881cites it

What has FDA decided for it lately?

  • K882001Diacare Monitoring SystemHealthware Corp. · 1988

The one decision as Healthware Corp. →