FDA applicant

Racal Filter Technologies, Inc.

Brockville, Ontario, CA2 decisions1997–19970 recalls

FDA records 2 decisions for Racal Filter Technologies, Inc. (Brockville, Ontario, CA) in 1997: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). Its devices cite 3 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, general and plastic surgery panel, where it files most

How often FDA has decided Racal Filter Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Racal Filter Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Racal Filter Technologies, 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 “Racal”

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

Racal Health & Safety, Inc. 3

Racal Filter Technologies, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Racal”