Cleared Traditional

K864726 - I/A/KPE TIP

K864726 is an FDA 510(k) clearance for I/A/KPE TIP, manufactured by Ipax, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K864726 · Ipax, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
85d
Days
Class 2
Risk

K864726 is an FDA 510(k) clearance for the I/A/KPE TIP. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ipax, Inc. devices

FDA 510(k) Submission Details - K864726

510(k) Number K864726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date January 20, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
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 123
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K864726.
SITE ULTRASONIC I/A PHACO NEEDLE
K882103 · Site Microsurgical Systems, Inc. · Jul 1988
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K871854 · CooperVision, Inc. · Jul 1987
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K871485 · Site Microsurgical Systems, Inc. · Jun 1987
SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)
K864301 · Site Microsurgical Systems, Inc. · Dec 1986
SITE PHACO DISPOSABLE CASSETTE
K861060 · Site Microsurgical Systems, Inc. · May 1986
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
K854375 · CooperVision, Inc. · Dec 1985