510(k) Report

FDA applicant

Prestige Ameritech

North Richland Hills, TX6 decisions2006–20240 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Prestige Ameritech’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010: 12016: 22017: 12024: 1
2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Prestige Ameritech by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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) Report

Other applicant names beginning “Prestige”

FDA records each applicant name separately; these may or may not be the same firm.