510(k) · Cleared
ClearedAhmed Glaucoma Valve
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 Oct 24, 2016 as substantially equivalent to K925636 (New World Medical, Inc., 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1988. 3 later devices descend from it.
- Decided
- Oct 24, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K875099 (1988). 3 ancestors in all. 3 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 deviceK162060 Ahmed Glaucoma ValveNew World Medical, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK171451 Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK230975 Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK231051 Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView 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) | K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016 | — |
| +1 | K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017 | — |
| +1 | K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | 2023 | — |
| +2 | K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (2)
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 4…3 and the Baerveldt Glaucoma Implant, first marketed in 1991. The Ahmed™ Glaucoma Valve Model FP7 is a modification to the Ahmed™ Glaucoma Valve Model S2 (510(k) Number: K925636) in which the plate design and material have been modified. Predicate devices information 510(k) Number: K925636 Device Name: Ah… | 1993 |
| * | K905129 | Baerveldt Glaucoma ImplantSummary page 4…material have been modified. Predicate devices information 510(k) Number: K925636 Device Name: Ahmed™ Glaucoma Valve Model S2 Decision Date: 11/12/1993 510(k) Number: K905129 Device Name: Baerveldt Glaucoma Implant Decision Date: 02/11/1991… | 1991 |
What descends from it? (3)
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 28 years and passes through 2 companies; a new generation was cleared every 22.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K171451 (New World Medical, Inc., 2017) has gone furthest, with 1 descendant 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. 2016, this device’s year, is highlighted.
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 medications, congenital or infantile glaucoma, and
refractory glaucomas resulting from aphakia or uveitis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162060: Ahmed Glaucoma Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162060
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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