510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813161Substantially Equivalent

Flo Tem II (Blood/fluid Warmer

Datachem, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813161 is the FDA 510(k) clearance record for FLO TEM II (BLOOD/FLUID WARMER, a class II device, cleared for Datachem, Inc. on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list 5 510(k) clearances for Datachem, Inc., from to . As of , FDA records show no recalls naming K813161.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Datachem, Inc. 4221 Richmond Rd., NW, Walker MI
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