510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152088Substantially Equivalent

IV-eye

Novarix Limited, Abingdon, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152088 is the FDA 510(k) clearance record for IV-eye, a class I device, cleared for Novarix Limited on under FDA product code KZA (Device, Vein Location, Liquid Crystal). FDA records list one 510(k) clearance for Novarix Limited. As of , FDA records show no recalls naming K152088.

Clearance record

Decision date
Received
(212 days to decision)
Product code
KZA Device, Vein Location, Liquid Crystal
Regulation
21 CFR 880.6970
Device class
Class I
Review panel
General Hospital
Applicant
Novarix Limited The Core Business Centre, Milton Hill, Abingdon, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KZA

Trailing 12 months

FDA records hold no clearances under product code KZA in the trailing twelve months.

FDA records show no clearances under product code KZA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260