Cleared Traditional

K931358 - AORP4000 REUSABLE PAK

K931358 is an FDA 510(k) clearance for AORP4000 REUSABLE 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 342-day FDA review.

K931358 · American Optical Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
342d
Days
Class 2
Risk

K931358 is an FDA 510(k) clearance for the AORP4000 REUSABLE 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 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

FDA 510(k) Submission Details - K931358

510(k) Number K931358 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.

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 K931358.
CASSETTE SYSTEM FOR SITE
K942518 · Surgin Surgical Instrumentation, Inc. · Jul 1994
OPHTHALMIC SURGICAL SYSTEM
K935223 · Optical Micro Systems, Inc. · Mar 1994
P4000 PHACOEMULSIFIER
K931354 · American Optical Corp. · Feb 1994
MODIFIED SITE TXR SYSTEMS
K925828 · Site Microsurgical Systems, Inc. · Feb 1994
AOD4000 DISPOSABLE PAK
K931357 · American Optical Corp. · Jan 1994
SITE'S CD II PHACOEMULSIFICATION HANDPIECE
K931866 · Site Microsurgical Systems, Inc. · Nov 1993