Krupin Eye Valve W/Scleral Buckle
FDA 510(k) K885125 · Hood Laboratories
510(k) numberK885125
Submission
- Device name
- Krupin Eye Valve W/Scleral Buckle
- Applicant
- Hood Laboratories
Pembroke, MA, US - Received
- December 12, 1988
- Decision date
- January 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYF – Implant, Eye Valve
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3920
- Specialty
- Ophthalmic
- Implant
- Yes
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|---|---|---|---|
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| 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 |
|---|---|---|
| K921452 | Acoustic RhinometerBXQ · Traditional | 07/08/1993SE |
| K920994 | Hood Nasal Septal ButtonLFB · Traditional | 05/15/1992SE |
| K905703 | Krupin Eye Valve with DiskKYF · Traditional | 03/15/1991SE |
| K904821 | Eliachar Modified Esophageal StentESW · Traditional | 01/14/1991SE |
| K897049 | Gibson Endolymphatic ShuntESZ · Traditional | 03/16/1990SE |
| K897059 | Hood Speaking ValveJOH · Traditional | 03/12/1990SE |
| K893866 | Hood Pediatric Tracheostomy TubeBTO · Traditional | 08/07/1989SE |
| K884810 | Silicone Laryngeal StentFWN · Traditional | 05/10/1989SE |
| K890599 | Hood Nasal SplintEPP · Traditional | 03/17/1989SE |
| K882430 | Hood Tracheal Stoma ButtonBTO · Traditional | 06/28/1988SE |
Questions and answers
When was Krupin Eye Valve W/Scleral Buckle cleared by the FDA?
Krupin Eye Valve W/Scleral Buckle (K885125) received a 510(k) decision of Substantially Equivalent on January 24, 1989, 43 days after the submission was received.
What is the product code of K885125?
The FDA product code is KYF – Implant, Eye Valve, a Class II (moderate risk) device regulated under 21 CFR 886.3920.