Cleared Traditional

K220891 - Kahook Dual Blade Glide (KDB Glide) (FDA 510(k) Clearance)

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

K220891 · New World Medical, Inc. · Ophthalmic device
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May 2024
Decision
781d
Days
Class 2
Risk

K220891 is an FDA 510(k) clearance for the Kahook Dual Blade Glide (KDB Glide). Classified as Knife, Intraocular Pressure Lowering (product code QUQ), Class II - Special Controls.

Submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 17, 2024 after a review of 781 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 878.4400 - 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 New World Medical, Inc. devices

Submission Details

510(k) Number K220891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2022
Decision Date May 17, 2024
Days to Decision 781 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
671d slower than avg
Panel avg: 110d · This submission: 781d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QUQ Knife, Intraocular Pressure Lowering
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition A Knife Intended For Cutting Of Trabecular Meshwork To Reduce Intraocular Pressure In Glaucoma
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.