510(k) Report

FDA applicant

Medax Srl Unipersonale

Poggio Rusco, IT6 decisions2011–20200 recalls

FDA records 6 decisions for Medax Srl Unipersonale (Poggio Rusco, IT) from 2011 to 2020: 6 510(k) clearances. All are in product code KNW (Instrument, Biopsy). Since 2016 its 510(k)s took a median of 173 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medax Unipersonale Srl”.

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 Medax Srl Unipersonale’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2011: 12015: 12017: 12018: 12020: 2
2011high 2 (2020) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Medax Srl Unipersonale by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medax Srl Unipersonale’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?

  • KNWInstrument, Biopsy6decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 173 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K181803Medax Biopsy Systems IIIMedax Srl Unipersonale · 20183cite it
  • K142125New Medax Biopsy SystemsMedax Srl Unipersonale · 20151cites it
  • K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale · 20171cites it
  • K192101Medone Ultra, MedextraMedax Srl Unipersonale · 20201cites it
  • K092338Medax Unipersonale SRLMedax Unipersonale Srl · 20111cites it

What has FDA decided for it lately?

  • K192101Medone Ultra, MedextraMedax Srl Unipersonale · 2020
  • K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and…Medax Srl Unipersonale · 2020
  • K181803Medax Biopsy Systems IIIMedax Srl Unipersonale · 2018
  • K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale · 2017
  • K142125New Medax Biopsy SystemsMedax Srl Unipersonale · 2015
  • K092338Medax Unipersonale SRLMedax Unipersonale Srl · 2011

All 5 as Medax Srl Unipersonale →The one decision as Medax Unipersonale Srl →