FDA applicant
Prestige Ameritech
FDA records 6 decisions for Prestige Ameritech (North Richland Hills, TX) from 2006 to 2024: 6 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and OXZ (Pediatric/Child Facemask). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Prestige Ameritech , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Prestige Ameritech’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Prestige Ameritech’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 “Prestige”
FDA records each applicant name separately; these may or may not be the same firm.