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 Aug 8, 2017 as substantially equivalent to K162060 (New World Medical, Inc., 2016) and 1 other predicate after an 83-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Aug 8, 2017
- Review
- 83 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K875099 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK875099 Molteno Valve SetonStaar Surgical Co. · 1988
- 2 generations backK925636 Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 1993
- 1 generation backK980657 Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998
- This deviceK171451 Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK231051 Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875099 | Molteno Valve Seton | Staar Surgical Co. | 1988 | — |
| −2 | K925636 | Ahmed Glaucoma Valve Implant | New World Medical, Inc. | 1993 | — |
| −1 | K980657 | Ahmed Glaucoma Valve, Model S3 | New World Medical, Inc. | 1998 | — |
| 0 (this device) | K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K162060 | Ahmed Glaucoma ValveSummary page 4…del FP8 Product Code KYF) o Predicate Device The two predicate devices are the Ahmed® Glaucoma Valve Model FP7 (K162060) and the Ahmed® Glaucoma Valve Model S3 (K980657). The Ahmed® Glaucoma Valve Model FP8 is a modification to the size of the predi… | 2016 |
| * | K980657 | Ahmed Glaucoma Valve, Model S3Summary page 4…Product Code KYF) o Predicate Device The two predicate devices are the Ahmed® Glaucoma Valve Model FP7 (K162060) and the Ahmed® Glaucoma Valve Model S3 (K980657). The Ahmed® Glaucoma Valve Model FP8 is a modification to the size of the predicate Model FP7. Predicate devices information 51… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231051 | Ahmed® Glaucoma Valve Model FP8 | 2023 | 0 |
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 29 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K231051 (New World Medical, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162060.
How does its category compare?
All KYF devicesKYF Implant, Eye Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 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/K171451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171451: 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/K171451
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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