FDA applicant
Well Lead Medical Instruments
FDA records 4 decisions for Well Lead Medical Instruments (Apollo Beach, FL) from 2005 to 2008: 4 510(k) clearances. Most are in product codes BTR (Tube, Tracheal (W/Wo Connector)) and BTO (Tube, Tracheostomy (W/Wo Connector)). Its devices cite 9 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Well Lead Medical Instruments’s devices, and how often a recall has named them.
FDA decisions per year
2in 2008
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Well Lead Medical Instruments’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) ReportOther applicant names beginning “Well”
FDA records each applicant name separately; these may or may not be the same firm.