# Bioteque Corp.

- Location (FDA's records): Flaggstaff, AZ
- FDA decisions: 14 (1992–2025): 14 510(k) clearances
- Names in FDA's records: Bioteque Corp. (11); Bioteque Corporation (3)
- Product codes: FGE (4), FPA (2), FJK (2), FAD (1), DRE (1), FIE (1), FOZ (1), HHK (1), DQO (1)
- 510(k) review time since 2016: median 346 days, against 111 for FDA's reviews in the same codes and years (0 of 4 faster)
- Predicates its devices cite: 16 (4 its own); citations of its devices by later devices: 9 (4 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
- Uresil Corp.: 2 (https://510kreport.com/company/uresil)
- Nipro Medical Corporation: 2 (https://510kreport.com/company/nipro-medical)
- Terumo America, Inc.: 1 (https://510kreport.com/company/terumo-america)
- Exel Intl.: 1 (https://510kreport.com/company/exel-intl)
- Rusch Intl.: 1 (https://510kreport.com/company/rusch-intl)
- Merit Medical Systems, Inc.: 1 (https://510kreport.com/company/merit-medical-systems)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)
- Seratronics, Inc.: 1 (https://510kreport.com/company/seratronics)

## Firms that cite its devices most
- Canyon Medical, Inc.: 2 (https://510kreport.com/company/canyon-medical)
- Cook, Inc.: 1 (https://510kreport.com/company/cook)
- Marina Medical Instruments, Inc.: 1 (https://510kreport.com/company/marina-medical-instruments)
- Cook Ireland, Ltd.: 1 (https://510kreport.com/company/cook-ireland)

## Its most-cited devices
- K200103: BIOTEQ Drainage Catheter Set (One Step Type) (2020), cited by 3
- K210419: BIOTEQ Drainage Catheter BT-PDS-series (2022), cited by 2
- K033210: Bioteq Double Pigtail Ureteral Stent Set (2004), cited by 2
- K033862: Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock (2005), cited by 1
- K915491: Curelle (1992), cited by 1

## Recent decisions
- K251019: BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (Dec 22, 2025)
- K210419: BIOTEQ Drainage Catheter BT-PDS-series (Apr 13, 2022)
- K200103: BIOTEQ Drainage Catheter Set (One Step Type) (Oct 9, 2020)
- K150932: Sheath Introducer (Jul 22, 2016)
- K102633: Bioteq Angiographic Catheter (Sep 9, 2011)
- K033862: Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String Lock (Feb 14, 2005)
- K033210: Bioteq Double Pigtail Ureteral Stent Set (Dec 30, 2004)
- K032292: Bioteque a.V. Fistula Needle Set with Safety Flex (Mar 22, 2004)

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