# Halyard Health - Irvine

- Location (FDA's records): Irvine, CA
- FDA decisions: 1 (2016–2016): 1 510(k) clearance
- Product codes: KOI (1)
- Predicates its devices cite: 1 (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
- Life-Tech Intl., Inc.: 1 (https://510kreport.com/company/life-tech-intl)

## Recent decisions
- K162048: EZstim*III Peripheral Nerve Stimulator/Nerve Locator (Dec 5, 2016)

Source page: https://510kreport.com/company/halyard-health-irvine