FDA applicant

Beckman Coulter Ireland, Inc.

Co. Clare, IE7 decisions2013–20194 recalls

FDA records 7 decisions for Beckman Coulter Ireland, Inc. (Co. Clare, IE) from 2013 to 2019: 7 510(k) clearances. Most are in product codes JZG (System, Test, Beta-2-Microglobulin Immunological) and JIX (Calibrator, Multi-Analyte Mixture). Its devices cite 8 predicates, 0 of them its own earlier devices. 4 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, clinical chemistry panel, where it files most

How often FDA has decided Beckman Coulter Ireland, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013high 3 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2025

2013high 3 (2023) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Beckman Coulter Ireland, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Beckman Coulter Ireland, 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 “Beckman”

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

Beckman Coulter, Inc. 286 Beckman Instruments, Inc. 281 Beckman-Diagnostic Systems Group 11 Beckman 6 Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. 2 Beckman Analytical and Biotechnology Development 1 Beckman Coulter Cellular 1 Beckman Coulter Biomedical GmbH 1

Beckman Coulter Ireland, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Beckman”