510(k) · Cleared
Recalled · Class II · 2019XEN Glaucoma Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · KYF Implant, Eye Valve
Cleared on Nov 21, 2016 as substantially equivalent to K925636 (New World Medical, Inc., 1993) and 1 other predicate after a 179-day review. Its family tree reaches back 4 generations to 1988. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 21, 2016
- Review
- 179 days
- Class
- Class II
- Product code
- KYF
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K875099 (1988). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK012852 EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS…Optonol, Ltd. · 2002
- This deviceK161457 XEN Glaucoma Treatment SystemAllergan, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK220032 iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022 · cites it directly0descendants
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 | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions | Optonol, Ltd. | 2002 | — |
| 0 (this device) | K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016 | — |
| +1 | K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K925636 | Ahmed Glaucoma Valve ImplantSummary page 4…Class II (special controls) Device Product Code: KYF (“Implant, Eye Valve”) III. PREDICATE DEVICES Ahmed Glaucoma Valve Implant, Model S2 (K925636) EX-PRESS Glaucoma Filtration Device (formerly referred to as the Ex-Press Mini Glaucoma Implant (K012852)) XEN G… | 1993 |
| * | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsSummary page 4…VICES Ahmed Glaucoma Valve Implant, Model S2 (K925636) EX-PRESS Glaucoma Filtration Device (formerly referred to as the Ex-Press Mini Glaucoma Implant (K012852)) XEN Glaucoma Treatment System Allergan IV. DEVICE D… | 2002 |
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 |
|---|---|---|---|
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2019 | Class II | Z-0598-2020 | Vendor change control | Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K220032 (Glaukos Corporation, 2022) has gone furthest, with 0 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. 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 XEN Glaucoma Treatment System is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161457: XEN Glaucoma Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161457
Report an extraction error
Are you the manufacturer?
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