Product code KYF
- Device name
- Implant, Eye Valve
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.3920
- Review panel
- OP
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230975 | Ahmed® Glaucoma Valve Model FP7 | New World Medical, Inc. | 2023-05-12 |
| K231051 | Ahmed® Glaucoma Valve Model FP8 | New World Medical, Inc. | 2023-05-12 |
| K220032 | iStent infinite Trabecular Micro-Bypass System, Model iS3 | Glaukos Corporation | 2022-08-02 |
| K182518 | AHMED ClearPath Glaucoma Drainage Device | New World Medical, Inc. | 2019-01-18 |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | 2017-08-08 |
| K161457 | XEN Glaucoma Treatment System | Allergan, Inc. | 2016-11-21 |
| K162060 | Ahmed Glaucoma Valve | New World Medical, Inc. | 2016-10-24 |
| K152996 | Molteno3 Glaucoma Implant | Innovative Ophthalmic Products, Inc. (Iop) | 2015-12-17 |
| K062252 | MOLTENO3 | Iop, Inc. | 2006-09-27 |
| K060644 | AHMED GLAUCOMA VALVE, MODEL M4 | New World Medical, Inc. | 2006-09-18 |
| K030350 | EXPRESS MINI GLAUCOMA SHUNT | Optonol, Ltd. | 2003-03-13 |
| K012852 | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS | Optonol, Ltd. | 2002-03-26 |
| K991072 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1999-07-13 |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | New World Medical, Inc. | 1998-04-20 |
| K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | Pharmacia Iovision, Inc. | 1997-02-18 |
| K925636 | AHMED GLAUCOMA VALVE IMPLANT | New World Medical, Inc. | 1993-11-12 |
| K905703 | KRUPIN EYE VALVE WITH DISK | Hood Laboratories | 1991-03-15 |
| K902296 | TRABECULO-SUPRACHOROIDAL SHUNT | Visionex, Inc. | 1991-03-14 |
| K905129 | BAERVELDT GLAUCOMA IMPLANT | Wright Medical Corp. | 1991-02-11 |
| K903462 | OPTIMED GLAUCOMA PRESSURE REGULATOR | Optimed, Inc. | 1990-10-16 |
| K902489 | MODIFIED MOLTENO(TM) IMPLANTS | Iop, Inc. | 1990-08-14 |
| K890598 | MOLTENO IMPLANT | Iop, Inc. | 1989-02-27 |
| K885125 | KRUPIN EYE VALVE W/SCLERAL BUCKLE | Hood Laboratories | 1989-01-24 |
| K875099 | MOLTENO VALVE SETON | Staar Surgical Co. | 1988-03-30 |
| K840204 | WHITE OCULAR PRESSURE RELIEF DEVICE | Precision-Cosmet Co., Inc. | 1985-02-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380650500045 | EX-PRESS | Alcon Laboratories, Inc. | 2025-09-23 |
| 00892064002089 | Ahmed ClearPath ST | NEW WORLD MEDICAL, INCORPORATED | 2024-12-18 |
| 00892064002096 | Ahmed ClearPath ST | NEW WORLD MEDICAL, INCORPORATED | 2024-12-18 |
| 00853704002449 | iStent Infinite | GLAUKOS CORPORATION | 2022-10-19 |
| 00853704002470 | iStent infinite | GLAUKOS CORPORATION | 2022-10-05 |
| 00892064002188 | Ahmed™ Glaucoma Valve | NEW WORLD MEDICAL, INCORPORATED | 2020-08-12 |
| 00892064002355 | Ahmed™ ClearPath | NEW WORLD MEDICAL, INCORPORATED | 2019-01-23 |
| 00892064002348 | Ahmed™ ClearPath | NEW WORLD MEDICAL, INCORPORATED | 2019-01-23 |
| 10888628032439 | XEN Glaucoma Treatment System | Allergan, Inc. | 2018-01-30 |
| 00892064002126 | Ahmed™ Glaucoma Valve | NEW WORLD MEDICAL, INCORPORATED | 2017-09-08 |
| 00892064002119 | Ahmed™ Glaucoma Valve | NEW WORLD MEDICAL, INCORPORATED | 2016-11-16 |
| 09419196000076 | Molteno | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000229 | Molteno3 | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000212 | Molteno3 | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000106 | Molteno3 | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000090 | Molteno3 | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000083 | Molteno | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000069 | Molteno | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000052 | Molteno | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000038 | Molteno | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000021 | Molteno | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 09419196000014 | Molteno | MOLTENO OPHTHALMIC LIMITED | 2016-08-12 |
| 00380650704948 | EX-PRESS® | Alcon Laboratories, Inc. | 2015-10-24 |
| 00380650704931 | EX-PRESS® | Alcon Laboratories, Inc. | 2015-10-24 |
| 05050474512993 | BAERVELDT GLAUCOMA IMPLANT (350) | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2015-09-15 |
| 05050474513006 | BAERVELDT PARS PLANA GLAUCOMA IMPLANT | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2015-09-15 |
| 05050474513013 | BAERVELDT GLAUCOMA IMPLANT (250) | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2015-09-15 |
| 00892064002133 | Ahmed™ Glaucoma Valve | NEW WORLD MEDICAL, INCORPORATED | 2015-03-24 |
| 00892064002270 | Ahmed™ Glaucoma Valve | NEW WORLD MEDICAL, INCORPORATED | 2015-03-24 |
| 00892064002140 | Ahmed™ Glaucoma Valve | NEW WORLD MEDICAL, INCORPORATED | 2015-03-24 |