# K013289: Bioteque Vaginal Pessaries

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque America, Inc.
- Decided: Dec 27, 2001 after 86 days
- Product code: HHW (Pessary, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3575
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K231786: Gynethotics™ Pessary (2024), 0 descendants of its own
- K031463: Marina Medical Silicone Pessary (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K013289
Methodology: https://510kreport.com/methodology