Cleared Traditional

K211618 - Fluido Compact Blood and Fluid Warming ...

K211618 is an FDA 510(k) clearance for Fluido Compact Blood and Fluid Warming ..., manufactured by The Surgical Company International B.V.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 740-day FDA review.

K211618 · The Surgical Company International B.V. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
740d
Days
Class 2
Risk

K211618 is an FDA 510(k) clearance for the Fluido Compact Blood and Fluid Warming System. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by The Surgical Company International B.V. (Amersfoort, NL). The FDA issued a Cleared decision on June 5, 2023 after a review of 740 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all The Surgical Company International B.V. devices

FDA 510(k) Submission Details - K211618

510(k) Number K211618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2021
Decision Date June 05, 2023
Days to Decision 740 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
611d slower than avg
Panel avg: 129d · This submission: 740d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGZ Device Classification - Class 2, Special Controls

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 18
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K211618.
Fluido Compact System
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