510(k) · Cleared
ClearedMolteno Valve Seton
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Staar Surgical Co. · KYF Implant, Eye Valve
Cleared on Mar 30, 1988 after a 111-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Mar 30, 1988
- Review
- 111 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK875099 Molteno Valve SetonStaar Surgical Co. · 1988
- Descendant · cites it directly · 9 of its ownK925636 Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 1993
- Descendant · 2 generations on · 6 of its ownK980657 Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK162060 Ahmed Glaucoma ValveNew World Medical, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK012852 EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS…Optonol, Ltd. · 2002
- Descendant · 3 generations on · 1 of its ownK171451 Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K925636Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 1993 · cites it directly9descendants
- K980657Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998 · 2 generations on6descendants
- K162060Ahmed Glaucoma ValveNew World Medical, Inc. · 2016 · 2 generations on3descendants
- K012852EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsOptonol, Ltd. · 2002 · 3 generations on3descendants
- K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K875099 | Molteno Valve Seton | Staar Surgical Co. | 1988 | — |
| +1 | K925636 | Ahmed Glaucoma Valve Implant | New World Medical, Inc. | 1993 | — |
| +2 | K980657 | Ahmed Glaucoma Valve, Model S3 | New World Medical, Inc. | 1998 | — |
| +2 | K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016 | — |
| +3 | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions | Optonol, Ltd. | 2002 | — |
| +3 | K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 KYF? 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 KYF device
- #1 K231051 Ahmed® Glaucoma Valve Model FP8score 6.2 · 4 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K925636 (New World Medical, Inc., 1993) has gone furthest, with 9 descendants of its own.
How does its category compare?
All KYF devicesKYF Implant, Eye Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KYF
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KYF
Too few KYF 510(k)s in any year since 2007 to give a median.
Recalls per year · KYF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KYF
268in 2025
MAUDE reports naming product code KYF, 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 | 5 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 116 |
| 2013 | 0 | — | 0 | 145 |
| 2014 | 0 | — | 0 | 288 |
| 2015 | 1 | — | 0 | 205 |
| 2016 | 2 | — | 0 | 198 |
| 2017 | 1 | — | 0 | 268 |
| 2018 | 0 | — | 0 | 258 |
| 2019 | 1 | — | 1 | 516 |
| 2020 | 0 | — | 0 | 437 |
| 2021 | 0 | — | 0 | 412 |
| 2022 | 1 | — | 0 | 299 |
| 2023 | 2 | — | 0 | 314 |
| 2024 | 0 | — | 0 | 312 |
| 2025 | 0 | — | 0 | 268 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K875099 · printed Nov 4, 2026
Cite this page
510(k) Report. “K875099: Molteno Valve Seton.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K875099
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026