Cleared Traditional

K931354 - P4000 PHACOEMULSIFIER

K931354 is the FDA 510(k) clearance for P4000 PHACOEMULSIFIER by American Optical Corp.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K931354 · American Optical Corp. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
342d
Days
Class 2
Risk

K931354 is an FDA 510(k) clearance for the P4000 PHACOEMULSIFIER. 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 February 22, 1994 after a review of 342 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 K931354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date February 22, 1994
Days to Decision 342 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
232d slower than avg
Panel avg: 110d · This submission: 342d
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 K931354.
IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
K944994 · Chiron Vision Corp. · Mar 1995
STORZ PHACOEMULSIFICATION NEEDLES
K946176 · Storz Instrument Co. · Feb 1995
STORZ PHACO AND FRAG HANDPIECES
K935926 · Storz Instrument Co. · Nov 1994
AORP4000 REUSABLE PAK
K931358 · American Optical Corp. · Feb 1994
AOD4000 DISPOSABLE PAK
K931357 · American Optical Corp. · Jan 1994
NIDEK CV-12000
K924260 · Nidek, Inc. · Mar 1993