FDA applicant

Abbott (St. Jude Medical)

Sylmar, CA6 decisions2019–20210 recalls

FDA records 6 decisions for Abbott (St. Jude Medical) (Sylmar, CA) from 2019 to 2021: 6 510(k) clearances. Most are in product codes MXC (Recorder, Event, Implantable Cardiac, (Without…) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 64 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 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 Abbott (St. Jude Medical)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2019high 4 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Abbott (St. Jude Medical) by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Abbott (St. Jude Medical)’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 “Abbott”

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

Abbott Laboratories 920 Abbott Medical 92 Abbott Vascular 64 Abbott Diabetes Care, Inc. 42 Abbott Molecular, Inc. 33 Abbott Diagnostics 28 Abbott Point of Care, Inc. 22 Abbott Medical Optics, Inc. 16 Abbott Mfg., Inc. 14 Abbott 14 Abbott Spine, Inc. 13 Abbott Diagnostics Scarborough, Inc. 8

Abbott (St. Jude Medical)

Which product codes does it file in?

How long do its 510(k) reviews take?

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 “Abbott”