# Deroyal

- Location (FDA's records): Powell, TN
- FDA decisions: 5 (2002–2004): 5 510(k) clearances
- Product codes: FYA (2), EYC (1), KKX (1), KSR (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Primeline Medical Products, Inc.: 1 (https://510kreport.com/company/primeline-medical-products)

## Firms that cite its devices most
- Deroyal Industries, Inc.: 1 (https://510kreport.com/company/deroyal-industries)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Its most-cited devices
- K041416: Exac-Temp Foley Catheter and Clini-Temp Foley Catheter (2004), cited by 2

## Recent decisions
- K041416: Exac-Temp Foley Catheter and Clini-Temp Foley Catheter (Jul 2, 2004)
- K033057: Deroyal Surgical Gowns, Sterile, Non-Sterile (Nov 20, 2003)
- K031408: Deroyal Poly-Reinforced Surgical Gowns (Sterile, Non-Sterile) (Oct 15, 2003)
- K030908: Deroyal Surgical Drapes Backtable Cover (Aug 11, 2003)
- K020753: Deroyal Surgical, Umbilicup (Jun 13, 2002)

Source page: https://510kreport.com/company/deroyal