Cleared Traditional

K211800 - Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211800 · Quality IN Flow , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
546d
Days
Class 2
Risk

K211800 is an FDA 510(k) clearance for the Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warri.... Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Quality IN Flow , Ltd. (Rosh Ha’Ayin, IL). The FDA issued a Cleared decision on December 8, 2022 after a review of 546 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 Quality IN Flow , Ltd. devices

Submission Details

510(k) Number K211800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2021
Decision Date December 08, 2022
Days to Decision 546 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
418d slower than avg
Panel avg: 128d · This submission: 546d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K211800.
°M Warmer System with °M Station
K260988 · Mequ A/S · Apr 2026
Fluido Compact System
K252636 · The Surgical Company International B.V. · Nov 2025
Fluido® AirGuard System
K251733 · The Surgical Company International BV (As Tsc Life) · Sep 2025
°M Warmer System
K232107 · Mequ A/S · May 2024
Fluido Compact Blood and Fluid Warming System
K211618 · The Surgical Company International B.V. · Jun 2023
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
K202461 · Smisson-Cartledge Biomedical, LLC · Aug 2022