FDA applicant
Source Production & Equipment Co., Inc.
FDA records 3 decisions for Source Production & Equipment Co., Inc. (Saint Rose, LA) from 2006 to 2014: 3 510(k) clearances. Most are in product codes KXK (Source, Brachytherapy, Radionuclide) and JAQ (System, Applicator, Radionuclide…). Its devices cite 6 predicates, 0 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 Source Production & Equipment Co., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2008
Class I Class II/III not classified
Planning a device like Source Production & Equipment Co., 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) ReportOther applicant names beginning “Source”
FDA records each applicant name separately; these may or may not be the same firm.