510(k) Report

FDA applicant

Qxmedical, LLC

Saint Paul, MN5 decisions2012–20200 recalls

FDA records 5 decisions for Qxmedical, LLC (Saint Paul, MN) from 2012 to 2020: 5 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and MJN (Catheter, Intravascular Occluding, Temporary). Since 2016 its 510(k)s took a median of 117 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 7 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 Qxmedical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12013: 12016: 12019: 12020: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Qxmedical, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Qxmedical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQYCatheter, Percutaneous4decisions
  • MJNCatheter, Intravascular Occluding, Temporary1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 117 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 117 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K123311Qxmedical Access & Support CatheterQxmedical, LLC · 20133cite it
  • K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 20122cite it
  • K183679Occlusion Balloon CatheterQxmedical, LLC · 20192cite it

What has FDA decided for it lately?

  • K200317Support CatheterQxmedical, LLC · 2020
  • K183679Occlusion Balloon CatheterQxmedical, LLC · 2019
  • K160561Boosting CatheterQxmedical, LLC · 2016
  • K123311Qxmedical Access & Support CatheterQxmedical, LLC · 2013
  • K120381Q50 Plus Stent Graft Balloon CatheterQxmedical, LLC · 2012

All 5 as Qxmedical, LLC →