510(k) · Cleared
ClearedEX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optonol, Ltd. · KYF Implant, Eye Valve
Cleared on Mar 26, 2002 as substantially equivalent to K980657 (New World Medical, Inc., 1998) and 3 other predicates after a 214-day review. Its family tree reaches back 3 generations to 1988. 3 later devices descend from it.
- Decided
- Mar 26, 2002
- Review
- 214 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K875099 (1988). 6 ancestors in all. 3 later devices descend from it, 2 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 deviceK012852 EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS…Optonol, Ltd. · 2002
- Descendant · cites it directly · 1 of its ownK161457 XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK220032 iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022
- Descendant · cites it directly · 0 of its ownK030350 Express Mini Glaucoma ShuntOptonol, Ltd. · 2003
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 |
|---|---|---|---|---|---|
| −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) | 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 |
| +2 | K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | 2022 | — |
| +1 | K030350 | Express Mini Glaucoma Shunt | Optonol, Ltd. | 2003 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K980657 | Ahmed Glaucoma Valve, Model S3Summary page 1…ressure in patients with glaucoma from failed medical therapy and failed prior surgical intervention. The device is substantially equivalent to the Ahmed Glaucoma Valve (K980657), the OptiMed Glaucoma Shunt (K903462) and the Baerveldt Glaucoma Shunt (K905129 and K955455). DESCRIPTION of the DEVICE: The E… | 1998 |
| * | K903462 | Optimed Glaucoma Pressure RegulatorSummary page 1…failed medical therapy and failed prior surgical intervention. The device is substantially equivalent to the Ahmed Glaucoma Valve (K980657), the OptiMed Glaucoma Shunt (K903462) and the Baerveldt Glaucoma Shunt (K905129 and K955455). DESCRIPTION of the DEVICE: The Ex-PRESS™ Miniature Glaucoma Implant de… | 1990 |
| * | K905129 | Baerveldt Glaucoma ImplantSummary page 1…rgical intervention. The device is substantially equivalent to the Ahmed Glaucoma Valve (K980657), the OptiMed Glaucoma Shunt (K903462) and the Baerveldt Glaucoma Shunt (K905129 and K955455). DESCRIPTION of the DEVICE: The Ex-PRESS™ Miniature Glaucoma Implant device is a stainless steel tube with a blunt… | 1991 |
| * | K955455 | Baervelt Pars Plana Glaucoma ImplantSummary page 1…vention. The device is substantially equivalent to the Ahmed Glaucoma Valve (K980657), the OptiMed Glaucoma Shunt (K903462) and the Baerveldt Glaucoma Shunt (K905129 and K955455). DESCRIPTION of the DEVICE: The Ex-PRESS™ Miniature Glaucoma Implant device is a stainless steel tube with a blunt needle shap… | 1997 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K161457 (Allergan, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K980657.
How does its category compare?
All KYF devicesKYF Implant, Eye Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Ex-PRESS™ Miniature Glaucoma Implant is intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
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/K012852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012852: EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012852
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026