Cleared Traditional

K963434 - VISCOUS FLUID SYSTEM

K963434 is an FDA 510(k) clearance for VISCOUS FLUID SYSTEM, manufactured by Escalon Trek Medical. The device is a Class 2 Ophthalmic device with product code MRH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K963434 · Escalon Trek Medical · Ophthalmic device
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Nov 1996
Decision
87d
Days
Class 2
Risk

K963434 is an FDA 510(k) clearance for the VISCOUS FLUID SYSTEM. Classified as Pump, Infusion, Ophthalmic (product code MRH), Class II - Special Controls.

Submitted by Escalon Trek Medical (Mukwonago, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5725 - 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 Escalon Trek Medical devices

FDA 510(k) Submission Details - K963434

510(k) Number K963434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1996
Decision Date November 25, 1996
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRH Device Classification - Class 2, Special Controls

Product Code MRH Pump, Infusion, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.