510(k) Report

FDA applicant

Naslund Medical AB

Huddinge, SE4 decisions2009–20220 recalls

FDA records 4 decisions for Naslund Medical AB (Huddinge, SE) from 2009 to 2022: 4 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 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, radiology panel, where it files most

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

FDA decisions per year

1in 2022

2009: 12016: 12020: 12022: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Naslund Medical AB by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Naslund Medical AB’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?

  • IYEAccelerator, Linear, Medical4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 106 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 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.

  • K160209Gold AnchorNaslund Medical AB · 20161cites it
  • K201117Gold AnchorNaslund Medical AB · 20201cites it
  • K091645Gold AnchorNaslund Medical AB · 20091cites it

What has FDA decided for it lately?

  • K213053Gold AnchorNaslund Medical AB · 2022
  • K201117Gold AnchorNaslund Medical AB · 2020
  • K160209Gold AnchorNaslund Medical AB · 2016
  • K091645Gold AnchorNaslund Medical AB · 2009

All 4 as Naslund Medical AB →