510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002409Substantially Equivalent

Maxone, Blood, Blood Products and IV Fluid Warmer

Automatic Medical Technologies, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002409 is the FDA 510(k) clearance record for MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER, a class II device, cleared for Automatic Medical Technologies, Inc. on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list 2 510(k) clearances for Automatic Medical Technologies, Inc., from to . As of , FDA records show no recalls naming K002409.

Clearance record

Decision date
Received
(325 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Automatic Medical Technologies, Inc. 3422 W. Pico Blvd., Los Angeles CA
510(k) summary
Summary
Third party review
No

Clearances, product code LGZ

Trailing 12 months
3 clearances under product code LGZ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LGZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260