Cleared Traditional

K905129 - BAERVELDT GLAUCOMA IMPLANT

K905129 is an FDA 510(k) clearance for BAERVELDT GLAUCOMA IMPLANT, manufactured by Wright Medical Corp.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K905129 · Wright Medical Corp. · Ophthalmic device
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Feb 1991
Decision
89d
Days
Class 2
Risk

K905129 is an FDA 510(k) clearance for the BAERVELDT GLAUCOMA IMPLANT. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Wright Medical Corp. (Peapack, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3920 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wright Medical Corp. devices

FDA 510(k) Submission Details - K905129

510(k) Number K905129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1990
Decision Date February 11, 1991
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYF Device Classification - Class 2, Special Controls

Product Code KYF Implant, Eye Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - KYF Implant, Eye Valve

All 16
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K905129.
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · New World Medical, Inc. · Apr 1998
BAERVELT PARS PLANA GLAUCOMA IMPLANT
K955455 · Pharmacia Iovision, Inc. · Feb 1997
KRUPIN EYE VALVE WITH DISK
K905703 · Hood Laboratories · Mar 1991
KRUPIN EYE VALVE W/SCLERAL BUCKLE
K885125 · Hood Laboratories · Jan 1989
MOLTENO VALVE SETON
K875099 · Staar Surgical Co. · Mar 1988