510(k) Report

FDA applicant

Bts S.P.A.

Padova, IT2 decisions2014–20160 recalls

FDA records 2 decisions for Bts S.P.A. (Padova, IT) from 2014 to 2016: 2 510(k) clearances. Most are in product codes KZM (Device, Muscle Monitoring) and LXJ (Interactive Rehabilitation Exercise Devices). Its devices cite 2 predicates, 0 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, physical medicine panel, where it files most

How often FDA has decided Bts S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Bts S.P.A. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KZMDevice, Muscle Monitoring1decision
  • LXJInteractive Rehabilitation Exercise Devices1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K131660Smart (Smart-D, Smart-DX)Bts S.P.A. · 20141cites it

What has FDA decided for it lately?

  • K161716Teethan 2.0Bts S.P.A. · 2016
  • K131660Smart (Smart-D, Smart-DX)Bts S.P.A. · 2014

All 2 as Bts S.P.A. →