510(k) · Cleared
ClearedAhmed Glaucoma Valve, Model S3
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 Apr 20, 1998 as substantially equivalent to K925636 (New World Medical, Inc., 1993) after a 74-day review. Its family tree reaches back 2 generations to 1988. 6 later devices descend from it.
- Decided
- Apr 20, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K875099 (1988). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK875099 Molteno Valve SetonStaar Surgical Co. · 1988
- 1 generation backK925636 Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 1993
- This deviceK980657 Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998
- 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 · cites it directly · 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 ownK231051 Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK220032 iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- 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 · cites it directly1descendant
- K161457XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · 2 generations on1descendant
- K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023 · 2 generations on0descendants
- K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875099 | Molteno Valve Seton | Staar Surgical Co. | 1988 | — |
| −1 | K925636 | Ahmed Glaucoma Valve Implant | New World Medical, Inc. | 1993 | — |
| 0 (this device) | K980657 | Ahmed Glaucoma Valve, Model S3 | New World Medical, Inc. | 1998 | — |
| +1 | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions | Optonol, Ltd. | 2002 | — |
| +1 | K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017 | — |
| +2 | K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016 | 1 |
| +2 | K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | 2023 | — |
| +3 | K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K925636 | Ahmed Glaucoma Valve ImplantSummary page 1…alence is demonstrated is the Ahmed™ Glaucdma Valve Implant Model S2, as manufactured by New World Medical, Incorporated, and described in their Premarket Notification, K925636. The new Device is Ahmed™ Glaucoma Valve Model S3, K980657. (4) Device Description The Ahmed™ Glaucoma Valve (AGV™) is a ophth… | 1993 |
What descends from it? (6)
2 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K012852 (Optonol, Ltd., 2002) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K925636.
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 glaucomas, where previous surgical treatment has failed, or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.
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/K980657 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980657: Ahmed Glaucoma Valve, Model S3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980657
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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