510(k) Report

FDA applicant

Wellspect AB

Mölndal, SE3 decisions2025–20260 recalls

FDA records 3 decisions for Wellspect AB (Mölndal, SE) from 2025 to 2026: 3 510(k) clearances. All are in product code EZD (Catheter, Straight). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided Wellspect AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 2
2025high 2 (2026) · low 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Wellspect AB by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EZDCatheter, Straight3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 59 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K250659LoFric OrigoWellspect AB · 20251cites it

What has FDA decided for it lately?

  • K261658LoFric Origo Pro CoudéWellspect AB · 2026
  • K260999LoFric Elle ProWellspect AB · 2026
  • K250659LoFric OrigoWellspect AB · 2025

All 3 as Wellspect AB →

Other applicant names beginning “Wellspect”

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

Wellspect Healthcare 1