# K920187: Flexible Silicone Gelihorn

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque America, Inc.
- Decided: Oct 23, 1992 after 283 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993308: Mentor Evacare Vaginal Pessaries (1999), 2 descendants of its own
- K253698: Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support; Milex™ Cube Pessaries; Milex™ Cube Pessaries with Drainage Holes (2026), 0 descendants of its own
- K250438: CooperSurgical Milex® Pessaries (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K920187
Methodology: https://510kreport.com/methodology