510(k) Report

FDA applicant

St. Jude Medical Systems AB

Uppsala, SE5 decisions2011–20140 recalls

FDA records 5 decisions for St. Jude Medical Systems AB (Uppsala, SE) from 2011 to 2014: 5 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and DXO (Transducer, Pressure, Catheter Tip). Its devices cite 8 predicates, 2 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 St. Jude Medical Systems AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 22013: 22014: 1
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — St. Jude Medical Systems AB by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2decisions
  • DXOTransducer, Pressure, Catheter Tip2decisions
  • DXCClamp, Vascular1decision

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 20134cite it
  • K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB · 20141cites it

What has FDA decided for it lately?

  • K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB · 2014
  • K133587Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB · 2013
  • K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
  • K111854AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb ReceiverSt. Jude Medical Systems AB · 2011
  • K110193Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II Plus Arch…St. Jude Medical Systems AB · 2011

All 5 as St. Jude Medical Systems AB →