Cleared Traditional

K931357 - AOD4000 DISPOSABLE PAK

K931357 is an FDA 510(k) clearance for AOD4000 DISPOSABLE PAK, manufactured by American Optical Corp.. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K931357

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.

HQC Device Classification - Class 2, Special Controls

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 193
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K931357.
P4000 PHACOEMULSIFIER
K931354 · American Optical Corp. · Feb 1994
AORP4000 REUSABLE PAK
K931358 · American Optical Corp. · Feb 1994
MODIFIED SITE TXR SYSTEMS
K925828 · Site Microsurgical Systems, Inc. · Feb 1994
SITE'S CD II PHACOEMULSIFICATION HANDPIECE
K931866 · Site Microsurgical Systems, Inc. · Nov 1993
NIDEK CV-12000
K924260 · Nidek, Inc. · Mar 1993
MODIFIED SITE MACROBORE PHACO NEEDLE
K922595 · Chiron Vision Corp. · Aug 1992