FDA applicant
American Telecare, Inc.
FDA records 9 decisions for American Telecare, Inc. (Eden Prairie, MN) from 1995 to 2003: 9 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and DQD (Stethoscope, Electronic). Its devices cite 3 predicates, 3 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
How often FDA has decided American Telecare, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for American Telecare, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like American Telecare, 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