510(k) · Cleared
ClearedBaerveldt Glaucoma Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wright Medical Corp. · KYF Implant, Eye Valve
Cleared on Feb 11, 1991 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Feb 11, 1991
- Review
- 89 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK905129 Baerveldt Glaucoma ImplantWright Medical Corp. · 1991
- Descendant · cites it directly · 3 of its ownK162060 Ahmed Glaucoma ValveNew World Medical, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK012852 EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS…Optonol, Ltd. · 2002
- Descendant · 2 generations on · 1 of its ownK171451 Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK161457 XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK230975 Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K162060Ahmed Glaucoma ValveNew World Medical, Inc. · 2016 · cites it directly3descendants
- K012852EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsOptonol, Ltd. · 2002 · cites it directly3descendants
- K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017 · 2 generations on1descendant
- K161457XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · 2 generations on1descendant
- K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905129 | Baerveldt Glaucoma Implant | Wright Medical Corp. | 1991 | — |
| +1 | K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016 | — |
| +1 | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions | Optonol, Ltd. | 2002 | — |
| +2 | K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017 | — |
| +2 | K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016 | 1 |
| +2 | K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (9)
3 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, K162060 (New World Medical, Inc., 2016) has gone furthest, with 3 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/K905129 · printed Nov 3, 2026
Cite this page
510(k) Report. “K905129: Baerveldt Glaucoma Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905129
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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