Cleared Traditional

K152088 - IV-eye (FDA 510(k) Clearance)

Class I General Hospital device.

K152088 · Novarix Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
212d
Days
Class 1
Risk

K152088 is an FDA 510(k) clearance for the IV-eye. Classified as Device, Vein Location, Liquid Crystal (product code KZA), Class I - General Controls.

Submitted by Novarix Limited (Abingdon, GB). The FDA issued a Cleared decision on February 24, 2016 after a review of 212 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6970 - the FDA general hospital 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Novarix Limited devices

Submission Details

510(k) Number K152088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2015
Decision Date February 24, 2016
Days to Decision 212 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 128d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZA Device, Vein Location, Liquid Crystal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6970
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.