# Blue Focus

- Location (FDA's records): Lawrenceville, GA
- FDA decisions: 1 (2013–2013): 1 510(k) clearance
- Product codes: ERA (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Jedmed Instrument Co.: 1 (https://510kreport.com/company/jedmed-instrument)

## Recent decisions
- K123821: Aio HD Otoscope (May 17, 2013)

Source page: https://510kreport.com/company/blue-focus