FDA applicant

Schiller America, Inc.

Tustin, CA10 decisions1990–19980 recalls

FDA records 10 decisions for Schiller America, Inc. (Tustin, CA) from 1990 to 1998: 10 510(k) clearances. Most are in product codes LOS (Unnamed device) and DPS (Electrocardiograph). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Schiller America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Schiller America, 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 “Schiller”

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

Schiller AG 18 Schiller Medical S.A. 1

Schiller America, 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?

Other applicant names beginning “Schiller”