510(k) Report

FDA applicant

M.D.L. S.R.L.

Delebio (So), IT1 decision2016–20161 recall

FDA records 1 decision for M.D.L. S.R.L. (Delebio (So), IT) in 2016: 1 510(k) clearance. All are in product code KNW (Instrument, Biopsy). Its devices cite 4 predicates, 0 of them its own earlier devices. 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided M.D.L. S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2016high 1 (2021) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — M.D.L. S.R.L. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNWInstrument, Biopsy1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable…M.D.L. S.R.L. · 20164cite it

What has FDA decided for it lately?

  • K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable…M.D.L. S.R.L. · 20161 recall

The one decision as M.D.L. S.R.L. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K160316Soft Tissue Biopsy NeedlesAug 5, 2021Class II