FDA applicant
Alpha Omega Engineering, Ltd.
FDA records 9 decisions for Alpha Omega Engineering, Ltd. (Nazareth, IL) from 1981 to 2025: 9 510(k) clearances. Most are in product codes GZL (Electrode, Depth) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 205 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.
FDA’s records also spell it “Alpha Omega Engineering Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alpha Omega Engineering, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Alpha Omega Engineering, Ltd.’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 “Alpha”
FDA records each applicant name separately; these may or may not be the same firm.