Ahmed Glaucoma Valve Implant
FDA 510(k) K991072 · New World Medical, Inc.
510(k) numberK991072
Submission
- Device name
- Ahmed Glaucoma Valve Implant
- Applicant
- New World Medical, Inc.
Rancho Cucamonga, CA, US - Received
- March 31, 1999
- Decision date
- July 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYF – Implant, Eye Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3920
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code KYF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231051 | Ahmed® Glaucoma Valve Model FP8KYF · Special | New World Medical, Inc. | 05/12/2023SE |
| K230975 | Ahmed® Glaucoma Valve Model FP7KYF · Special | New World Medical, Inc. | 05/12/2023SE |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3KYF · Traditional | Glaukos Corporation | 08/02/2022SE |
| K182518 | AHMED ClearPath Glaucoma Drainage DeviceKYF · Traditional | New World Medical, Inc. | 01/18/2019SE |
| K171451 | Ahmed Glaucoma Valve Model FP8KYF · Traditional | New World Medical, Inc. | 08/08/2017SE |
| K161457 | XEN Glaucoma Treatment SystemKYF · Traditional | Allergan, Inc. | 11/21/2016SE |
| K162060 | Ahmed Glaucoma ValveKYF · Traditional | New World Medical, Inc. | 10/24/2016SE |
| K152996 | Molteno3 Glaucoma ImplantKYF · Traditional | Innovative Ophthalmic Products, Inc. (Iop) | 12/17/2015SE |
| K062252 | MOLTENO3KYF · Traditional | Iop, Inc. | 09/27/2006SE |
| K060644 | Ahmed Glaucoma Valve, Model M4KYF · Traditional | New World Medical, Inc. | 09/18/2006SE |
More from New World Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243503 | VIA360 Surgical SystemMRH · Traditional | 02/14/2025SE |
| K220891 | Kahook Dual Blade Glide (KDB Glide)QUQ · Traditional | 05/17/2024SE |
| K231051 | Ahmed® Glaucoma Valve Model FP8KYF · Special | 05/12/2023SE |
| K230975 | Ahmed® Glaucoma Valve Model FP7KYF · Special | 05/12/2023SE |
| K211680 | Streamline Surgical SystemMRH · Traditional | 10/08/2021SE |
| K182518 | AHMED ClearPath Glaucoma Drainage DeviceKYF · Traditional | 01/18/2019SE |
| K171451 | Ahmed Glaucoma Valve Model FP8KYF · Traditional | 08/08/2017SE |
| K162060 | Ahmed Glaucoma ValveKYF · Traditional | 10/24/2016SE |
| K060644 | Ahmed Glaucoma Valve, Model M4KYF · Traditional | 09/18/2006SE |
| K980657 | Ahmed Glaucoma Valve, Model S3KYF · Traditional | 04/20/1998SE |
Questions and answers
When was Ahmed Glaucoma Valve Implant cleared by the FDA?
Ahmed Glaucoma Valve Implant (K991072) received a 510(k) decision of Substantially Equivalent on July 13, 1999, 104 days after the submission was received.
What is the product code of K991072?
The FDA product code is KYF – Implant, Eye Valve, a Class II (moderate risk) device regulated under 21 CFR 886.3920.