Cleared Traditional

K052074 - JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS

Also marketed or referenced as:
JSZ-WET-TREE AND JSZ-WET-OR, WETTING,

K052074 is an FDA 510(k) clearance for JSZ-STAT-TREE, manufactured by Szabocsik and Associates. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K052074 · Szabocsik and Associates · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
31d
Days
Class 2
Risk

K052074 is an FDA 510(k) clearance for the JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Szabocsik and Associates (Chicago, US). The FDA issued a Cleared decision on September 1, 2005 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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 Szabocsik and Associates devices

FDA 510(k) Submission Details - K052074

510(k) Number K052074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2005
Decision Date September 01, 2005
Days to Decision 31 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 110d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRC Device Classification - Class 2, Special Controls

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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 - MRC Products, Contact Lens Care, Rigid Gas Permeable

All 24
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K052074.
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
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MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K082855 · Menicon Co, Ltd. · Mar 2010
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · Bausch & Lomb, Incorporated · May 2003
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K023455 · Ciba Vision Corporation · Feb 2003
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · Menicon Co, Ltd. · May 2002