# Alpha Omega Engineering, Ltd.

- Location (FDA's records): Nazareth, IL
- FDA decisions: 9 (1981–2025): 9 510(k) clearances
- Names in FDA's records: Alpha Omega Engineering , Ltd. (8); Alpha Omega Engineering Corp. (1)
- Product codes: GZL (8), FLL (1)
- 510(k) review time since 2016: median 205 days, against 90 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alpha Omega, Ltd.: 1 (https://510kreport.com/company/alpha-omega)
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)

## Its most-cited devices
- K120098: Sterile Disposables for Mer (2012), cited by 1
- K220553: Neuro Omega System, NeuroSmart System (2022), cited by 1
- K172042: NeuroNav System, NeuroSmart System (2018), cited by 1
- K123796: Neuro Omega System (2013), cited by 1
- K171581: Neuro Omega System (2017), cited by 1

## Recent decisions
- K250601: Neuro Omega System; NeuroSmart System (Mar 30, 2025)
- K220553: Neuro Omega System, NeuroSmart System (Sep 16, 2022)
- K191739: Sterile LeadConfirm (Jan 2, 2020)
- K172042: NeuroNav System, NeuroSmart System (Feb 27, 2018)
- K171581: Neuro Omega System (Dec 22, 2017)
- K123796: Neuro Omega System (Apr 5, 2013)
- K120098: Sterile Disposables for Mer (Jun 12, 2012)
- K052527: Neuroprobes (Apr 12, 2006)

Source page: https://510kreport.com/company/alpha-omega-engineering