510(k) Report

FDA applicant

Dantec Medical, Inc.

Washington, DC25 decisions1990–19960 recalls

FDA records 25 decisions for Dantec Medical, Inc. (Washington, DC) from 1990 to 1996: 25 510(k) clearances. Most are in product codes FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic…) and GWF (Stimulator, Electrical, Evoked Response). Its devices cite 4 predicates, 1 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, neurology panel, where it files most

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

FDA decisions per year

No FDA decision for Dantec Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Dantec Medical, Inc.’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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Other applicant names beginning “Dantec”

FDA records each applicant name separately; these may or may not be the same firm.