510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K894111Substantially Equivalent

Vari-Set

Sonex Medical, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894111 is the FDA 510(k) clearance record for VARI-SET, a class II device, cleared for Sonex Medical on under FDA product code LDR (Controller, Infusion, Intravascular, Electronic). FDA records list one 510(k) clearance for Sonex Medical. As of , FDA records show no recalls naming K894111.

Clearance record

Decision date
Received
(108 days to decision)
Product code
LDR Controller, Infusion, Intravascular, Electronic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Sonex Medical 2511 S. W. Temple, Salt Lake City UT
Third party review
No

Clearances, product code LDR

Trailing 12 months

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

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