510(k) · Cleared
ClearedAhmed Glaucoma Valve Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New World Medical, Inc. · KYF Implant, Eye Valve
Cleared on Nov 12, 1993 as substantially equivalent to K875099 (Staar Surgical Co., 1988) after a 368-day review. Its family tree reaches back 1 generation to 1988. 9 later devices descend from it.
- Decided
- Nov 12, 1993
- Review
- 368 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K875099 (1988). 9 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK875099 Molteno Valve SetonStaar Surgical Co. · 1988
- This deviceK925636 Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 1993
- Descendant · cites it directly · 6 of its ownK980657 Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK162060 Ahmed Glaucoma ValveNew World Medical, Inc. · 2016
- Descendant · 2 generations on · 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 · cites it directly · 1 of its ownK161457 XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K980657Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998 · cites it directly6descendants
- 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 · 2 generations on3descendants
- K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017 · 2 generations on1descendant
- K161457XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875099 | Molteno Valve Seton | Staar Surgical Co. | 1988 | — |
| 0 (this device) | K925636 | Ahmed Glaucoma Valve Implant | New World Medical, Inc. | 1993 | — |
| +1 | K980657 | Ahmed Glaucoma Valve, Model S3 | New World Medical, Inc. | 1998 | — |
| +1 | K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016 | — |
| +2 | 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 | — |
| +1 | K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K875099 | Molteno Valve SetonSummary page 1…ubstantial Equivalence is demonstrated is the Single Plate Molteno Valve Implant, as ‘manufactured by STaAAR Surgical Co., and described in their Premarket Notification, K875099, (4) Device Description: The Ahmed™ Glaucoma Valve (AGV) is a new ophthalmic implant for use in intractable glaucoma. The devic… | 1988 |
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?
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 | — |
What is it indicated for?
The Ahmed Glaucoma Valve is indicated for the management of refractory glaucoma where previous surgical treatment has failed, or experience is known to provide unsatisfactory results. Refractory glaucoma can include primary open angle glaucoma unresponsive to medication, primary neovascular glaucoma and other types of glaucoma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K925636 · printed Nov 5, 2026
Cite this page
510(k) Report. “K925636: Ahmed Glaucoma Valve Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925636
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026