Cleared Traditional

Fluido? AirGuard System

K251733 · The Surgical Company International BV (As Tsc Life) · General Hospital

Sep 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K251733 is an FDA 510(k) clearance for the Fluido? AirGuard System, a Warmer, Thermal, Infusion Fluid (Class II — Special Controls, product code LGZ), submitted by The Surgical Company International BV (As Tsc Life) (Amsterdam, NL). The FDA issued a Cleared decision on September 4, 2025, 90 days after receiving the submission on June 6, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K251733 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2025
Decision Date	September 04, 2025
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF