510(k) · Cleared
ClearedBaervelt Pars Plana Glaucoma Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia Iovision, Inc. · KYF Implant, Eye Valve
Cleared on Feb 18, 1997 after a 447-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Feb 18, 1997
- Review
- 447 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK955455 Baervelt Pars Plana Glaucoma ImplantPharmacia Iovision, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK012852 EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS…Optonol, Ltd. · 2002
- Descendant · 2 generations on · 1 of its ownK161457 XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK220032 iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022
- Descendant · cites it directly · 0 of its ownK182518 AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK030350 Express Mini Glaucoma ShuntOptonol, Ltd. · 2003
Most influential descendants
Showing 5 of 5 · See all- K012852EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsOptonol, Ltd. · 2002 · cites it directly3descendants
- K161457XEN Glaucoma Treatment SystemAllergan, Inc. · 2016 · 2 generations on1descendant
- K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022 · 3 generations on0descendants
- K182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. · 2019 · cites it directly0descendants
- K030350Express Mini Glaucoma ShuntOptonol, Ltd. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955455 | Baervelt Pars Plana Glaucoma Implant | Pharmacia Iovision, Inc. | 1997 | — |
| +1 | K012852 | EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS Versions | Optonol, Ltd. | 2002 | — |
| +2 | K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016 | 1 |
| +3 | K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | 2022 | — |
| +1 | K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | 2019 | — |
| +2 | K030350 | Express Mini Glaucoma Shunt | Optonol, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | — | Baerveldt Glaucoma Implant Named without a submission number |
What descends from it? (5)
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?
- Of its descendants, K012852 (Optonol, Ltd., 2002) has gone furthest, with 3 descendants of its own.
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 Baerveldt Pars Plana Glaucoma Implant is intended for use in patients with medically uncontrollable glaucoma with poor surgical prognosis.
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/K955455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955455: Baervelt Pars Plana Glaucoma Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955455
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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