510(k) Report

FDA applicant

Sapimed S.P.A.

Crofton, MD3 decisions2007–20071 recall

FDA records 3 decisions for Sapimed S.P.A. (Crofton, MD) in 2007: 3 510(k) clearances. Most are in product codes FER (Anoscope And Accessories) and KDM (Sigmoidoscope, Rigid, Non-Electrical). Its devices cite 6 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 Sapimed S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2007

2007: 3
2007high 3 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sapimed 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?

  • FERAnoscope And Accessories1decision
  • KDMSigmoidoscope, Rigid, Non-Electrical1decision
  • FHNLigator, Hemorrhoidal1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 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.

  • K070913Self-Light Disposable AnoscopeSapimed S.P.A. · 20075cite it
  • K070915Sapimed Disposable SigmoidoscopeSapimed S.P.A. · 20072cite it
  • K070881Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 20072cite it

What has FDA decided for it lately?

  • K070881Lem Hemorrhoidal Ligator, Models a.5650, a.5660Sapimed S.P.A. · 2007
  • K070913Self-Light Disposable AnoscopeSapimed S.P.A. · 20071 recall
  • K070915Sapimed Disposable SigmoidoscopeSapimed S.P.A. · 20071 recall

All 3 as Sapimed S.P.A. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070913Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product…Apr 23, 2021Class II