510(k) Report

FDA applicant

Sarmed Srl

Medolla, IT1 decision2007–20070 recalls

FDA records 1 decision for Sarmed Srl (Medolla, IT) in 2007: 1 510(k) clearance. All are in product code KLA (Monitor, Esophageal Motility, Anorectal…). Its devices cite 3 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, gastroenterology and urology panel, where it files most

How often FDA has decided Sarmed Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sarmed Srl’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K062362Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry CathetersSarmed Srl · 2007

The one decision as Sarmed Srl →