510(k) · Cleared
ClearedFlexible Silicone Gelihorn
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteque America, Inc. · HHW Pessary, Vaginal
Cleared on Oct 23, 1992 after a 283-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 23, 1992
- Review
- 283 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK920187 Flexible Silicone GelihornBioteque America, Inc. · 1992
- Descendant · cites it directly · 2 of its ownK993308 Mentor Evacare Vaginal PessariesMentor Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK253698 Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish…Cooper Surgical · 2026
- Descendant · 2 generations on · 0 of its ownK250438 CooperSurgical Milex® PessariesCooperSurgical, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K993308Mentor Evacare Vaginal PessariesMentor Corp. · 1999 · cites it directly2descendants
- K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support…Cooper Surgical · 2026 · 2 generations on0descendants
- K250438CooperSurgical Milex® PessariesCooperSurgical, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920187 | Flexible Silicone Gelihorn | Bioteque America, Inc. | 1992 | — |
| +1 | K993308 | Mentor Evacare Vaginal Pessaries | Mentor Corp. | 1999 | — |
| +2 | K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with… | Cooper Surgical | 2026 | — |
| +2 | K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HHW device
- #1 K253698 Milex™ Incontinence Dish Pessaries; Milex™…score 11.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993308 | Mentor Evacare Vaginal Pessaries | 1999 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993308 (Mentor Corp., 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HHW
263in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HHW
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHW
39in 2025
MAUDE reports naming product code HHW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 9 | 0 |
| 2014 | 2 | — | 2 | 5 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 401 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 5 | 263 | 0 | 6 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K920187 · printed Nov 4, 2026
Cite this page
510(k) Report. “K920187: Flexible Silicone Gelihorn.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920187
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026