510(k) Report

FDA applicant

Capenergy Medical S.L.

Sant Joan Despi, Barcelona, ES3 decisions2020–20260 recalls

FDA records 3 decisions for Capenergy Medical S.L. (Sant Joan Despi, Barcelona, ES) from 2020 to 2026: 3 510(k) clearances. All are in product code PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 225 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, general and plastic surgery panel, where it files most

How often FDA has decided Capenergy Medical S.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12023: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Capenergy Medical S.L. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PBXMassager, Vacuum, Radio Frequency Induced Heat3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 269 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 225 days; 0 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 3 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.

  • K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. · 20232cite it
  • K191202Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L. · 20201cites it

What has FDA decided for it lately?

  • K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L. · 2026
  • K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L. · 2023
  • K191202Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L. · 2020

All 3 as Capenergy Medical S.L. →