510(k) · Cleared
ClearedAhmed® Glaucoma Valve Model FP8
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 May 12, 2023 as substantially equivalent to K171451 (New World Medical, Inc., 2017) after a 29-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- May 12, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K875099 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK875099 Molteno Valve SetonStaar Surgical Co. · 1988
- 3 generations backK925636 Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 1993
- 2 generations backK980657 Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998
- 1 generation backK171451 Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017
- This deviceK231051 Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875099 | Molteno Valve Seton | Staar Surgical Co. | 1988 | — |
| −3 | K925636 | Ahmed Glaucoma Valve Implant | New World Medical, Inc. | 1993 | — |
| −2 | K980657 | Ahmed Glaucoma Valve, Model S3 | New World Medical, Inc. | 1998 | — |
| −1 | K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017 | — |
| 0 (this device) | 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 |
| 2016 | 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 K230975 Ahmed® Glaucoma Valve Model FP7score 5.9 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K171451 | Ahmed Glaucoma Valve Model FP8Summary page 4…eous Shunt (21 CFR 886.3920) Product Code: KYF Device Class: Class II – Ophthalmic Panel d) Predicate Device 510(k) Number: K171451 Device Name: Ahmed® Glaucoma Valve Model FP8 Decision Date: 08/08/2017… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All KYF devicesKYF Implant, Eye Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Model FP8 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/K231051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231051: Ahmed® Glaucoma Valve Model FP8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231051
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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