510(k) Report

FDA applicant

Pascal Medical AB

Minneapolis, MN1 decision1999–19990 recalls

FDA records 1 decision for Pascal Medical AB (Minneapolis, MN) in 1999: 1 510(k) clearance. All are in product code ETY (Tester, Auditory Impedance). Its devices cite 1 predicate, 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Pascal Medical AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pascal Medical AB 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?

  • ETYTester, Auditory Impedance1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K991562Pascal Medical AB Meniett 20Pascal Medical AB · 1999

The one decision as Pascal Medical AB →

Other applicant names beginning “Pascal”

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

Pascal Co., Inc. 8Pascal Mathieux 1