510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K801145Substantially Equivalent

Smi Multi-Tube Vortexer

Scientific Manufacturing Industries, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801145 is the FDA 510(k) clearance record for SMI MULTI-TUBE VORTEXER, a class I device, cleared for Scientific Manufacturing Industries on under FDA product code JRQ (Shaker/Stirrer). FDA records list 2 510(k) clearances for Scientific Manufacturing Industries, from to . As of , FDA records show no recalls naming K801145.

Clearance record

Decision date
Received
(27 days to decision)
Product code
JRQ Shaker/Stirrer
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Scientific Manufacturing Industries 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JRQ

Trailing 12 months

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

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