# Bivona Medical Technologies

- Location (FDA's records): Gary, IN
- FDA decisions: 50 (1978–1995): 50 510(k) clearances
- Product codes: JOH (15), EWL (8), BTR (8), BTO (6), EMX (2), KDL (1), BSR (1), FAD (1), BTL (1), LYA (1), HIR (1), HDP (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 21 (0 its own)
- Recalls linked to its devices: 61 (28 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Tracoe Medical GmbH: 4 (https://510kreport.com/company/tracoe-medical)
- Arcadia Medical Corporation: 4 (https://510kreport.com/company/arcadia-medical)
- Coloplast Corp.: 3 (https://510kreport.com/company/coloplast)
- Atos Medical AB: 3 (https://510kreport.com/company/atos-medical)
- Rusch Intl.: 2 (https://510kreport.com/company/rusch-intl)
- Engineered Medical Systems: 1 (https://510kreport.com/company/engineered-medical-systems)
- Porges Corp.: 1 (https://510kreport.com/company/porges)
- Portex, Inc.: 1 (https://510kreport.com/company/portex)

## Its most-cited devices
- K881744: Porges Ureteral Stent (1988), cited by 4
- K821568: Blow-Singer Tracheostoma Valve (1982), cited by 3
- K852272: Bivona Tracheostoma Valve II (1985), cited by 2
- K862267: Fome-Cuf and Aire Cuf Tracheostomy Tubes (1986), cited by 2
- K912469: Bivona Wire Reinforced Pediatric Tracheostomy Tube (1991), cited by 2
- K913270: Bivona Fome-Cuf (R) Pediatric Tracheostomy Tube (1991), cited by 1

## Recent decisions
- K952700: Superslick (Oct 31, 1995)
- K942025: Burget Nasal Stent (Oct 27, 1995)
- K944178: Bivona Flextend Pediatric & Neonatal Tracheostromy Tubes (Oct 27, 1994)
- K935053: Bivona Nasal Turbinate Stent (Jul 1, 1994)
- K933398: Bivona Illuminated Endotracheal Tube (Oct 6, 1993)
- K931749: Bivona (R) Icu Endotracheal Tube (Aug 10, 1993)
- K922665: Bivona Hyperflex Tracheostomy Tube (Jan 7, 1993)
- K923878: Bivona Customized Tracheostomy Tubes (Dec 29, 1992)

Source page: https://510kreport.com/company/bivona-medical-technologies