KRUPIN EYE VALVE WITH DISK
FDA 510(k) clearance K905703 · decided 1991-03-15
Clearance details
- K-number
- K905703
- Device name
- KRUPIN EYE VALVE WITH DISK
- Applicant
- Hood Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1990-12-20
- Decision date
- 1991-03-15
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- KYF
- Device class
- 2
- Regulation number
- 886.3920
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Pembroke, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Ahmed® Glaucoma Valve Model FP7 (K230975) | New World Medical, Inc. | 2023-05-12 |
| Ahmed® Glaucoma Valve Model FP8 (K231051) | New World Medical, Inc. | 2023-05-12 |
| iStent infinite Trabecular Micro-Bypass System, Model iS3 (K220032) | Glaukos Corporation | 2022-08-02 |
| AHMED ClearPath Glaucoma Drainage Device (K182518) | New World Medical, Inc. | 2019-01-18 |
| Ahmed Glaucoma Valve Model FP8 (K171451) | New World Medical, Inc. | 2017-08-08 |
| XEN Glaucoma Treatment System (K161457) | Allergan, Inc. | 2016-11-21 |
| Ahmed Glaucoma Valve (K162060) | New World Medical, Inc. | 2016-10-24 |
| Molteno3 Glaucoma Implant (K152996) | Innovative Ophthalmic Products, Inc. (Iop) | 2015-12-17 |
| MOLTENO3 (K062252) | Iop, Inc. | 2006-09-27 |
| AHMED GLAUCOMA VALVE, MODEL M4 (K060644) | New World Medical, Inc. | 2006-09-18 |
| EXPRESS MINI GLAUCOMA SHUNT (K030350) | Optonol, Ltd. | 2003-03-13 |
| EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS (K012852) | Optonol, Ltd. | 2002-03-26 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Krupin Eye Valve, P/N 6003 recall (Z-0844-06) | Eagle Vision Inc | 2006-05-06 |
| Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V recall (Z-0845-06) | Eagle Vision Inc | 2006-05-06 |
| Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V recall (Z-0846-06) | Eagle Vision Inc | 2006-05-06 |
| Valve-EV Glaucoma Ultra-Smooth, P/N 6006 recall (Z-0847-06) | Eagle Vision Inc | 2006-05-06 |