510(k) Report

FDA applicant

H.S Hospital Service S.P.A

Aprilia (Lt), IT6 decisions2004–20240 recalls

FDA records 6 decisions for H.S Hospital Service S.P.A (Aprilia (Lt), IT) from 2004 to 2024: 6 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNW (Instrument, Biopsy). Since 2016 its 510(k)s took a median of 212 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 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 H.S Hospital Service S.P.A’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2009: 12015: 12019: 12024: 2
2007high 2 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — H.S Hospital Service S.P.A by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like H.S Hospital Service S.P.A’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • KNWInstrument, Biopsy2decisions
  • NEYSystem, Ablation, Microwave And Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 212 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 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.

  • K083157HS AmicaH.S Hospital Service S.P.A · 20092cite it
  • K033616Trapmatic System SetH.S Hospital Service S.P.A · 20041cites it
  • K182605HS AMICA devices familyH.S Hospital Service S.P.A · 20191cites it
  • K150112HS Amica Devices FamilyH.S Hospital Service S.P.A · 20151cites it

What has FDA decided for it lately?

  • K242029Trap EasyH.S Hospital Service S.P.A · 2024
  • K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A · 2024
  • K182605HS AMICA devices familyH.S Hospital Service S.P.A · 2019
  • K150112HS Amica Devices FamilyH.S Hospital Service S.P.A · 2015
  • K083157HS AmicaH.S Hospital Service S.P.A · 2009
  • K033616Trapmatic System SetH.S Hospital Service S.P.A · 2004

All 6 as H.S Hospital Service S.P.A →