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
K211618Substantially Equivalent

Fluido Compact Blood and Fluid Warming System

The Surgical Company International B.V., Amersfoort, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K211618 is the FDA 510(k) clearance record for Fluido Compact Blood and Fluid Warming System, a class II device, cleared for The Surgical Company International B.V. on under FDA product code LGZ (Warmer, Thermal, Infusion Fluid). FDA records list 3 510(k) clearances for The Surgical Company International B.V., from to . As of , FDA records show no recalls naming K211618.

Clearance record

Decision date
Received
(740 days to decision)
Product code
LGZ Warmer, Thermal, Infusion Fluid
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
The Surgical Company International B.V. Beeldschermweg 6f, Amersfoort, NL
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