FDA applicant
Medtimo, Inc.
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
How often FDA has decided Medtimo, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2007high 1 (2016) · low 0 (2007)2026
2026 so far, outlined.
Recalls per year
1in 2017
2007high 1 (2010) · low 0 (2007)2026
Class I Class II/III not classified
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.
See the 510(k) Report