FDA applicant

Pascal Co., Inc.

Bellevue, WA8 decisions1991–20101 recall

FDA records 8 decisions for Pascal Co., Inc. (Bellevue, WA) from 1991 to 2010: 8 510(k) clearances. Most are in product codes LBH (Varnish, Cavity) and EJR (Agent, Polishing, Abrasive, Oral Cavity). Its devices cite 8 predicates, 1 of them its own earlier devices. 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, dental panel, where it files most

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

FDA decisions per year

1in 2010

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pascal Co., Inc.’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

Other applicant names beginning “Pascal”

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

Pascal Medical AB 1 Pascal Mathieux 1

Pascal Co., Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Pascal”