Cleared Traditional

K955455 - BAERVELT PARS PLANA GLAUCOMA IMPLANT

K955455 is an FDA 510(k) clearance for BAERVELT PARS PLANA GLAUCOMA IMPLANT, manufactured by Pharmacia Iovision, Inc.. The device is a Class 2 Ophthalmic device with product code KYF cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K955455 · Pharmacia Iovision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
447d
Days
Class 2
Risk

K955455 is an FDA 510(k) clearance for the BAERVELT PARS PLANA GLAUCOMA IMPLANT. Classified as Implant, Eye Valve (product code KYF), Class II - Special Controls.

Submitted by Pharmacia Iovision, Inc. (Peapack, US). The FDA issued a Cleared decision on February 18, 1997 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Pharmacia Iovision, Inc. devices

FDA 510(k) Submission Details - K955455

510(k) Number K955455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date February 18, 1997
Days to Decision 447 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
337d slower than avg
Panel avg: 110d · This submission: 447d
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 11
Devices cleared under the same product code (KYF) and FDA review panel - the closest regulatory comparables to K955455.
XEN Glaucoma Treatment System
K161457 · Allergan, Inc. · Nov 2016
AHMED GLAUCOMA VALVE IMPLANT
K991072 · New World Medical, Inc. · Jul 1999
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · New World Medical, Inc. · Apr 1998
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