510(k) Report

FDA applicant

St. Jude Medical (Now Abbott Medical)

St. Paul, MN2 decisions2019–20190 recalls

FDA records 2 decisions for St. Jude Medical (Now Abbott Medical) (St. Paul, MN) in 2019: 2 510(k) clearances. Most are in product codes NQQ (System, Imaging, Optical Coherence Tomography…) and DQK (Computer, Diagnostic, Programmable). Its devices cite 4 predicates, 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, radiology panel, where it files most

How often FDA has decided St. Jude Medical (Now Abbott Medical)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2019: 2
2019high 2 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

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

Planning a device like St. Jude Medical (Now Abbott 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

Which product codes does it file in?

  • NQQSystem, Imaging, Optical Coherence Tomography (Oct)1decision
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 20193cite it
  • K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical) · 20192cite it

What has FDA decided for it lately?

  • K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical) · 2019
  • K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical) · 2019

All 2 as St. Jude Medical (Now Abbott Medical) →