Cleared Traditional

K922378 - OPHTHALMIC KNIFE

K922378 is an FDA 510(k) clearance for OPHTHALMIC KNIFE, manufactured by Microptics Development Laboratory. The device is a Class 1 Ophthalmic device with product code HNN cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K922378 · Microptics Development Laboratory · Ophthalmic device
Download Printable Device Report (PDF)
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Dec 1992
Decision
204d
Days
Class 1
Risk

K922378 is an FDA 510(k) clearance for the OPHTHALMIC KNIFE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Microptics Development Laboratory (Newport Beach, US). The FDA issued a Cleared decision on December 10, 1992 after a review of 204 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Microptics Development Laboratory devices

FDA 510(k) Submission Details - K922378

510(k) Number K922378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date December 10, 1992
Days to Decision 204 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
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

HNN Device Classification - Class 1, General Controls

Product Code HNN Knife, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNN Knife, Ophthalmic

All 23
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K922378.
CLEARCUT S SAFETY KNIFE
K110166 · Alcon Research, Ltd. · May 2011
MVR/STILETTO BLADE 20GA. - P/N 1900
K881669 · Advanced Surgical Products, Inc. · May 1988
PRISMA DISPOSABLE MVR/STILETTO BLADE
K874979 · Advanced Surgical Products, Inc. · Apr 1988
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
K864290 · Keeler Instruments, Inc. · Dec 1986
SAPPHIRE KNIFE BLADE
K861744 · Keeler Instruments, Inc. · Jun 1986
RUBY & SAPPHIRE BLADE HOLDER
K861748 · Keeler Instruments, Inc. · Jun 1986