Cleared Traditional

K874334 - SOLOS SINGLE USE TITANIUM TIP

K874334 is an FDA 510(k) clearance for SOLOS SINGLE USE TITANIUM TIP, manufactured by Solos Ophthalmology. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K874334 · Solos Ophthalmology · Ophthalmic device
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Jan 1988
Decision
81d
Days
Class 2
Risk

K874334 is an FDA 510(k) clearance for the SOLOS SINGLE USE TITANIUM TIP. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Solos Ophthalmology (Norcross, US). The FDA issued a Cleared decision on January 11, 1988 after a review of 81 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 Solos Ophthalmology devices

FDA 510(k) Submission Details - K874334

510(k) Number K874334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1987
Decision Date January 11, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 110d · This submission: 81d
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 198
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K874334.
SITE MACROBORE PHACO NEEDLE
K883099 · Site Microsurgical Systems, Inc. · Sep 1988
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
K883199 · Chiron Vision Corp. · Sep 1988
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
I/A/KPE TIP
K864726 · Ipax, Inc. · Jan 1987