510(k) Report

FDA applicant

Smart Solutions Technologies SL

Madrid, ES2 decisions2018–20230 recalls

FDA records 2 decisions for Smart Solutions Technologies SL (Madrid, ES) from 2018 to 2023: 2 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) and DQK (Computer, Diagnostic, Programmable). 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, cardiovascular panel, where it files most

How often FDA has decided Smart Solutions Technologies SL’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2018: 12023: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Smart Solutions Technologies SL by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSHRecorder, Magnetic Tape, Medical1decision
  • DQKComputer, Diagnostic, Programmable1decision

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.

  • K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL · 20181cites it

What has FDA decided for it lately?

  • K231620Nuubo SmartSmart Solutions Technologies SL · 2023
  • K173461ECG recorder and Arrhythmia DetectorSmart Solutions Technologies SL · 2018

All 2 as Smart Solutions Technologies SL →