510(k) Report

FDA applicant

SmartWise Sweden AB

Tullinge, SE2 decisions2022–20260 recalls

FDA records 2 decisions for SmartWise Sweden AB (Tullinge, SE) from 2022 to 2026: 2 510(k) clearances. All are in product code KRA (Catheter, Continuous Flush). Its devices cite 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2022

2022: 12026 (partial year): 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — SmartWise Sweden AB by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KRACatheter, Continuous Flush2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB · 20221cites it

What has FDA decided for it lately?

  • K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
  • K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2022

All 2 as SmartWise Sweden AB →