510(k) Report

FDA applicant

Radi Medical Systems AB

Uppsala, SE24 decisions1990–20130 recalls

FDA records 24 decisions for Radi Medical Systems AB (Uppsala, SE) from 1990 to 2013: 24 510(k) clearances. Most are in product codes DXC (Clamp, Vascular) and DQK (Computer, Diagnostic, Programmable). Its devices cite 32 predicates, 21 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 Radi Medical Systems AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2008: 22009: 12013: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Radi Medical Systems AB by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Radi Medical Systems AB’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?

  • DXCClamp, Vascular8decisions
  • DQKComputer, Diagnostic, Programmable4decisions
  • DXOTransducer, Pressure, Catheter Tip4decisions
  • DQXWire, Guide, Catheter3decisions
  • DSKComputer, Blood-Pressure2decisions
  • GAANeedle, Aspiration And Injection, Disposable1decision

Also: JAK (1), QSY (1).

Whose devices does it build on?

Its devices cite 32 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 45 times; 21 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.

  • K092105Radianalyzer XpressRadi Medical Systems AB · 20098cite it
  • K024107Femostop Femoral Compression SystemRadi Medical Systems AB · 20025cite it
  • K915280FemostopRadi Medical Systems AB · 19924cite it
  • K080206Modification to Femostop Femoral Compression SystemRadi Medical Systems AB · 20083cite it
  • K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 20083cite it
  • K022188Radianalyzer, Model 12710Radi Medical Systems AB · 20022cite it

What has FDA decided for it lately?

  • K123984Quantien Measurement SystemRadi Medical Systems AB · 2013
  • K092105Radianalyzer XpressRadi Medical Systems AB · 2009
  • K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
  • K080206Modification to Femostop Femoral Compression SystemRadi Medical Systems AB · 2008
  • K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
  • K042628Modification to: Radianalyzer, Model 12711Radi Medical Systems AB · 2005
  • K033291Topseal Hemostatic Dressing, Model 11150Radi Medical Systems AB · 2004
  • K031662Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003

All 24 as Radi Medical Systems AB →