510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K033202Substantially Equivalent

Advantage Paddle

Livingston Products, Inc., Deer Field IL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033202 is the FDA 510(k) clearance record for ADVANTAGE PADDLE, a class II device, cleared for Livingston Products, Inc. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list one 510(k) clearance for Livingston Products, Inc. As of , FDA records show no recalls naming K033202.

Clearance record

Decision date
Received
(62 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Livingston Products, Inc. P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IZH

Trailing 12 months

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

FDA records show no clearances under product code IZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZH, 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