Cleared Traditional

K842197 - AMERICAN MEDICAL OPTICS I/A KIT- IRRIG

K842197 is an FDA 510(k) clearance for AMERICAN MEDICAL OPTICS I/A KIT- IRRIG, manufactured by American Medical Optics. The device is a Class 2 Ophthalmic device with product code HQE cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K842197 · American Medical Optics · Ophthalmic device
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Oct 1984
Decision
119d
Days
Class 2
Risk

K842197 is an FDA 510(k) clearance for the AMERICAN MEDICAL OPTICS I/A KIT- IRRIG. Classified as Instrument, Vitreous Aspiration And Cutting, Ac-powered (product code HQE), Class II - Special Controls.

Submitted by American Medical Optics (Walker, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4150 - 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 American Medical Optics devices

FDA 510(k) Submission Details - K842197

510(k) Number K842197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date October 01, 1984
Days to Decision 119 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 110d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQE Device Classification - Class 2, Special Controls

Product Code HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4150
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 - HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 88
Devices cleared under the same product code (HQE) and FDA review panel - the closest regulatory comparables to K842197.
O.M.S. GUILLOTINE CUTTER
K844374 · Optical Micro Systems, Inc. · Dec 1984
OMS SCISSORS
K844510 · Optical Micro Systems, Inc. · Dec 1984
AUTOMATED INTRAOCULAR SCISSORS
K842471 · Medical Instrument Development Laboratories, Inc. · Nov 1984
DISPOSABLE OCUTOME PROBE
K833371 · CooperVision, Inc. · Jan 1984
BAILEY ASPIRATOR/IRRIGATOR
K831584 · Medical Instrument Development Laboratories, Inc. · Aug 1983
DORC COMPACT MICRO SURGICAL SYSTEM
K830216 · Jedmed Instrument Co. · Mar 1983