Cleared Traditional

BAERVELT PARS PLANA GLAUCOMA IMPLANT (K955455) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955455 · Pharmacia Iovision, Inc. · Ophthalmic device
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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

Submission Details

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
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.

Device Classification

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 24
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