510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K890205Substantially Equivalent

Automix Compounder Y - Adaptor Set

Stedim, Inc., Walnut Creek CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890205 is the FDA 510(k) clearance record for AUTOMIX COMPOUNDER Y - ADAPTOR SET, a class II device, cleared for Stedim, Inc. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 3 510(k) clearances for Stedim, Inc., from to . As of , FDA records show no recalls naming K890205.

Clearance record

Decision date
Received
(282 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Stedim, Inc. 3667 Perada Dr., Walnut Creek CA
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260