510(k) · Cleared
ClearedExpress Mini Glaucoma Shunt
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 13, 2003 as substantially equivalent to K012852 (Optonol, Ltd., 2002) after a 38-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Mar 13, 2003
- Review
- 38 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K875099 (1988). 7 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 backK012852 EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS…Optonol, Ltd. · 2002
- This deviceK030350 Express Mini Glaucoma ShuntOptonol, Ltd. · 2003
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) | 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 |
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? (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 |
|---|---|---|---|
| * | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsSummary page 1…x-PRESSTMMini Glaucoma Shunt Model R30-1S and R50-1S is substantially equivalent to the predicate Optonol Ex-PRESS Models R30 and R50 Glaucoma Shunt cleared under 510(k) K012852. DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The blunt tipped Ex-PRESS Mini Glaucoma Shunts capture aqueous… | 2002 |
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 15 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K012852.
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-PRESSTMMiniature Glaucoma Family of Implants are intended to reduce
intraocular pressure in patients with glaucoma where medical and conventional surgical
treatments have failed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030350: Express Mini Glaucoma Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030350
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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