510(k) Report

FDA applicant

Medivators Reprocessing Systems

Minneapolis, MN3 decisions2007–20117 recalls

FDA records 3 decisions for Medivators Reprocessing Systems (Minneapolis, MN) from 2007 to 2011: 3 510(k) clearances. All are in product code FEB (Accessories, Cleaning, For Endoscope). Its devices cite 6 predicates, 1 of them its own earlier devices. 7 recalls are 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 Medivators Reprocessing Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007: 12009: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

3in 2026

2023: 12024: 32026 (partial year): 3
2007high 3 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Medivators”

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