510(k) · Cleared
ClearediStent infinite Trabecular Micro-Bypass System, Model iS3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glaukos Corporation · KYF Implant, Eye Valve
Cleared on Aug 2, 2022 as substantially equivalent to K161457 (Allergan, Inc., 2016) after a 209-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Aug 2, 2022
- Review
- 209 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K875099 (1988). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK875099 Molteno Valve SetonStaar Surgical Co. · 1988
- 4 generations backK925636 Ahmed Glaucoma Valve ImplantNew World Medical, Inc. · 1993
- 3 generations backK980657 Ahmed Glaucoma Valve, Model S3New World Medical, Inc. · 1998
- 2 generations backK012852 EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS…Optonol, Ltd. · 2002
- 1 generation backK161457 XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · Recalled
- This deviceK220032 iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K875099 | Molteno Valve Seton | Staar Surgical Co. | 1988 | — |
| −4 | K925636 | Ahmed Glaucoma Valve Implant | New World Medical, Inc. | 1993 | — |
| −3 | K980657 | Ahmed Glaucoma Valve, Model S3 | New World Medical, Inc. | 1998 | — |
| −2 | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions | Optonol, Ltd. | 2002 | — |
| −1 | K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016 | 1 |
| 0 (this device) | 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 |
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
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 |
|---|---|---|---|
| * | K161457 | XEN Glaucoma Treatment SystemSummary page 4…Class II (special controls) Device Product Code: KYF (“Implant, Eye Valve”) III. PREDICATE DEVICE • XEN Glaucoma Treatment System (K161457), 21 CFR 886.3920, Product Code KYF IV. DEVICE DESCRIPTION The iStent infinite Trabecular Micro-Bypass System Model iS3… | 2016 |
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 34 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All KYF devicesKYF Implant, Eye Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220032: iStent infinite Trabecular Micro-Bypass System, Model iS3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220032
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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