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
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K905062Substantially Equivalent

Injector, Insulin

Sound 2000 Medical Systems, Inc., Edina MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905062 is the FDA 510(k) clearance record for INJECTOR, INSULIN, a class II device, cleared for Sound 2000 Medical Systems, Inc. on under FDA product code KZE (Injector, Fluid, Non-Electrically Powered). FDA records list one 510(k) clearance for Sound 2000 Medical Systems, Inc. As of , FDA records show no recalls naming K905062.

Clearance record

Decision date
Received
(126 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
Sound 2000 Medical Systems, Inc. 7450 France Ave., S., Edina MN
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