Atlas FDA

KYF

25 FDA 510(k) clearances · Product code

90 daysmedian time to decision
368 days90th percentile
25clearances measured

FDA profile

Official device name
Implant, Eye Valve
Device class
Class II (moderate risk)
Regulation
21 CFR 886.3920
Medical specialty
Ophthalmic
Flags
Implant
Adverse events (MAUDE)
2021: 412 · 2022: 299 · 2023: 314 · 2024: 364 · 2025: 281 · 2026: 145
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
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 Corporation2022-08-02
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
AHMED GLAUCOMA VALVE IMPLANT (K991072)New World Medical, Inc.1999-07-13
AHMED GLAUCOMA VALVE, MODEL S3 (K980657)New World Medical, Inc.1998-04-20
BAERVELT PARS PLANA GLAUCOMA IMPLANT (K955455)Pharmacia Iovision, Inc.1997-02-18
AHMED GLAUCOMA VALVE IMPLANT (K925636)New World Medical, Inc.1993-11-12
KRUPIN EYE VALVE WITH DISK (K905703)Hood Laboratories1991-03-15
TRABECULO-SUPRACHOROIDAL SHUNT (K902296)Visionex, Inc.1991-03-14
BAERVELDT GLAUCOMA IMPLANT (K905129)Wright Medical Corp.1991-02-11
OPTIMED GLAUCOMA PRESSURE REGULATOR (K903462)Optimed, Inc.1990-10-16
MODIFIED MOLTENO(TM) IMPLANTS (K902489)Iop, Inc.1990-08-14
MOLTENO IMPLANT (K890598)Iop, Inc.1989-02-27
KRUPIN EYE VALVE W/SCLERAL BUCKLE (K885125)Hood Laboratories1989-01-24
MOLTENO VALVE SETON (K875099)Staar Surgical Co.1988-03-30
WHITE OCULAR PRESSURE RELIEF DEVICE (K840204)Precision-Cosmet Co., Inc.1985-02-15

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Every clearance here is in the API, with alerts when new ones post.