# Bioteque America, Inc.

- Location (FDA's records): Langhorne, PA
- FDA decisions: 10 (1992–2004): 10 510(k) clearances
- Product codes: HHW (3), HHT (1), LKF (1), KXP (1), HIB (1), HDX (1), HHK (1), DQF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 6 (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 that cite its devices most
- Mentor Corp.: 2 (https://510kreport.com/company/mentor)
- Marina Medical Instruments, Inc.: 1 (https://510kreport.com/company/marina-medical-instruments)
- KARL STORZ Endoscopy-America, Inc.: 1 (https://510kreport.com/company/karl-storz-endoscopy-america)
- Cosm Medical: 1 (https://510kreport.com/company/cosm-medical)
- Irvine Scientific Sales Co., Inc.: 1 (https://510kreport.com/company/irvine-scientific-sales)

## Its most-cited devices
- K013289: Bioteque Vaginal Pessaries (2001), cited by 2
- K041094: HSG Catheter Set (2004), cited by 1
- K920747: Pessary Flexible Silicone Donut Ring (1994), cited by 1
- K003380: Bioteque Vaginal Dilator (2001), cited by 1
- K920187: Flexible Silicone Gelihorn (1992), cited by 1

## Recent decisions
- K041094: HSG Catheter Set (Jun 17, 2004)
- K020628: Curelle, Preferred Curelle, Cuteq 2.5 (May 24, 2002)
- K013289: Bioteque Vaginal Pessaries (Dec 27, 2001)
- K003380: Bioteque Vaginal Dilator (Jan 29, 2001)
- K920633: Pessary Flexible Silicone Nichols (Nov 8, 1995)
- K920747: Pessary Flexible Silicone Donut Ring (Aug 29, 1994)
- K933628: Cytology Brush (Mar 11, 1994)
- K933521: Speculum (Mar 7, 1994)

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