510(k) Report

FDA applicant

Medtimo, Inc.

Eden Prairie2 decisions2001–20163 recalls

FDA records 2 decisions for Medtimo, Inc. (Eden Prairie) from 2001 to 2016: 2 original PMA approvals. All are in product code LTI (Implant, Intragastric For Morbid Obesity). 3 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 Medtimo, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2010: 12011: 12017: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medtimo, Inc.’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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