FDA applicant

Keystone Heart, Ltd.

Caesaria, IL1 decision2020–20200 recalls

FDA records 1 decision for Keystone Heart, Ltd. (Caesaria, IL) in 2020: 1 510(k) clearance. All are in product code DYB (Introducer, Catheter). 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 Keystone Heart, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Keystone Heart, Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Keystone Heart, Ltd.’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 “Keystone”

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

Keystone Dental, Inc. 8 Keystone X-Ray, Inc. 4 Keystone Industries 3 Keystone Veterinary Supplies, Inc. 3 Keystone Diagnostics, Inc. 2 Keystone Medical 2

Keystone Heart, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Keystone”