Cleared Traditional

K152088 - IV-eye

K152088 is an FDA 510(k) clearance for IV-eye, manufactured by Novarix Limited. The device is a Class 1 General Hospital device with product code KZA cleared through the Traditional 510(k) pathway after a 212-day FDA review.

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

FDA 510(k) Submission Details - K152088

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
83d slower than avg
Panel avg: 129d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

KZA Device Classification - Class 1, General Controls

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.