FDA applicant

Promepla Sam

Monaco, MC5 decisions2012–20180 recalls

FDA records 5 decisions for Promepla Sam (Monaco, MC) from 2012 to 2018: 5 510(k) clearances. Most are in product codes KNY (Accessories, Catheter, G-U) and OCX (Endoscopic Irrigation/Suction System). Its devices cite 9 predicates, 2 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 Promepla Sam’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2012high 2 (2018) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Promepla Sam by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Promepla Sam’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

Other applicant names beginning “Promepla”

FDA records each applicant name separately; these may or may not be the same firm.

Promepla 1

Promepla Sam

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Promepla”