FDA applicant
Flotec, Inc.
FDA records 2 decisions for Flotec, Inc. (Indianapolis, IN) from 1990 to 1997: 2 510(k) clearances. Most are in product codes CAN (Regulator, Pressure, Gas Cylinder) and NFB (Conserver, Oxygen). 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 Flotec, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Flotec, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Flotec, 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