FDA applicant

Sedecal USA, Inc.

Deer Field, IL3 decisions2001–20043 recalls

FDA records 3 decisions for Sedecal USA, Inc. (Deer Field, IL) from 2001 to 2004: 3 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and KPR (System, X-Ray, Stationary). Its devices cite 4 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Sedecal USA, Inc. since 2007.

Recalls per year

1in 2023

2007high 1 (2023) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sedecal USA, 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 “Sedecal”

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

Sedecal., Sa. 26

Sedecal USA, 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 “Sedecal”