510(k) · Cleared
ClearedAHMED ClearPath Glaucoma Drainage Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New World Medical, Inc. · KYF Implant, Eye Valve
Cleared on Jan 18, 2019 as substantially equivalent to K905129 (Wright Medical Corp., 1991) and 1 other predicate after a 127-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jan 18, 2019
- Review
- 127 days
- Class
- Class II
- Product code
- KYF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905129 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK905129 Baerveldt Glaucoma ImplantWright Medical Corp. · 1991
- This deviceK182518 AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905129 | Baerveldt Glaucoma Implant | Wright Medical Corp. | 1991 | — |
| 0 (this device) | K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K905129 | Baerveldt Glaucoma ImplantSummary page 4…II Device Product Code: KYF III. PREDICATE DEVICES Predicate devices information 510(k) Number: K905129 510(k) Number: K955455 Device Name: Baerveldt Glaucoma Implant (BGI) Device Name: Baerveld… | 1991 |
| * | K955455 | Baervelt Pars Plana Glaucoma ImplantSummary page 4…III. PREDICATE DEVICES Predicate devices information 510(k) Number: K905129 510(k) Number: K955455 Device Name: Baerveldt Glaucoma Implant (BGI) Device Name: Baerveldt Pars Plana Glaucoma Implant Decision Date:… | 1997 |
| † | K162060 | Ahmed Glaucoma Valve | 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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K905129.
How does its category compare?
All KYF devicesKYF Implant, Eye Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AHMED® ClearPath glaucoma drainage device is indicated for the management of refractory glaucoma where
previous surgical treatment has failed or is not expected to provide satisfactory results. Such refractory glaucoma may
include but is not limited to: neovascular glaucoma, congenital or infantile glaucoma, and refractory glaucoma resulting
from aphakia or uveitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182518: AHMED ClearPath Glaucoma Drainage Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182518
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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