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
K921797Substantially Equivalent

Preci-Jet 50

Hmi Industries, Inc., Rexdale, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921797 is the FDA 510(k) clearance record for PRECI-JET 50, a class II device, cleared for Hmi Industries, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list 3 510(k) clearances for Hmi Industries, Inc., from to . As of , FDA records show no recalls naming K921797.

Clearance record

Decision date
Received
(217 days to decision)
Product code
KZE Injector, Fluid, Non-Electrically Powered
Regulation
21 CFR 880.5430
Device class
Class II
Review panel
General Hospital
Applicant
Hmi Industries, Inc. 34 Greensboro Dr., Rexdale, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code KZE

Trailing 12 months

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

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