Cleared Traditional

K931357 - AOD4000 DISPOSABLE PAK

K931357 is the FDA 510(k) clearance for AOD4000 DISPOSABLE PAK by American Optical Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K931357 · American Optical Corp. · Ophthalmic device
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Jan 1994
Decision
314d
Days
Class 2
Risk

K931357 is an FDA 510(k) clearance for the AOD4000 DISPOSABLE PAK. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by American Optical Corp. (Irvine, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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. Elevated predicate reliance profile. 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 Optical Corp. devices

Submission Details

510(k) Number K931357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date January 25, 1994
Days to Decision 314 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
204d slower than avg
Panel avg: 110d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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 - HQC Unit, Phacofragmentation

All 87
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K931357.
STORZ PHACO AND FRAG HANDPIECES
K935926 · Storz Instrument Co. · Nov 1994
P4000 PHACOEMULSIFIER
K931354 · American Optical Corp. · Feb 1994
AORP4000 REUSABLE PAK
K931358 · American Optical Corp. · Feb 1994
NIDEK CV-12000
K924260 · Nidek, Inc. · Mar 1993
MODIFIED SITE MACROBORE PHACO NEEDLE
K922595 · Chiron Vision Corp. · Aug 1992
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
K921607 · Chiron Vision Corp. · Jun 1992