FDA product code KYF: Implant, Eye Valve
KYF is the FDA product code for implant, eye valve. It is a Class II device, regulated under 21 CFR 886.3920 and reviewed by the Ophthalmic panel. FDA has cleared 25 510(k) submissions under KYF, 3 in the last five years, from 13 different applicants. The average 510(k) review took 141 days (median 90). FDA has posted 6 recalls for KYF devices.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Eye Valve |
| Device class | Class II |
| Regulation | 21 CFR 886.3920 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KYF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 83 |
| 2019 | 1 | 127 |
| 2022 | 1 | 209 |
| 2023 | 2 | 33 |
Top KYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| New World Medical, Inc. | 9 | 2023-05-12 |
| Iop, Inc. | 3 | 2006-09-27 |
| Optonol, Ltd. | 2 | 2003-03-13 |
| Hood Laboratories | 2 | 1991-03-15 |
| Glaukos Corporation | 1 | 2022-08-02 |
8 more applicants have KYF clearances. See the full list in Caduvo.
Most recent KYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231051 | New World Medical, Inc. | Ahmed® Glaucoma Valve Model FP8 | 2023-05-12 | 29 |
| K230975 | New World Medical, Inc. | Ahmed® Glaucoma Valve Model FP7 | 2023-05-12 | 37 |
| K220032 | Glaukos Corporation | iStent infinite Trabecular Micro-Bypass System, Model iS3 | 2022-08-02 | 209 |
| K182518 | New World Medical, Inc. | AHMED ClearPath Glaucoma Drainage Device | 2019-01-18 | 127 |
| K171451 | New World Medical, Inc. | Ahmed Glaucoma Valve Model FP8 | 2017-08-08 | 83 |
Recalls for KYF devices
6 product recalls in 3 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2019-10-30.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code KYF?
KYF is the FDA product code for implant, eye valve. It is a Class II device, regulated under 21 CFR 886.3920 and reviewed by the Ophthalmic panel.
What device class is KYF?
Class II, regulation 21 CFR 886.3920. Typical premarket route: 510(k).
How long does a 510(k) take for product code KYF?
Across 25 cleared submissions the average was 141 days from receipt to decision (median 90).
Which companies have the most KYF clearances?
New World Medical, Inc. (9); Iop, Inc. (3); Optonol, Ltd. (2); Hood Laboratories (2); Glaukos Corporation (1).
Have KYF devices been recalled?
Yes: 6 product recalls across 3 recall events; the most recent began 2019-10-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KYF
- Run a recall and safety report across every KYF manufacturer
- Watch product code KYF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.