Cleared Special

K180154 - QiF Blood and Fluid Warmer (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K180154 · Quality IN Flow , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
98d
Days
Class 2
Risk

K180154 is an FDA 510(k) clearance for the QiF Blood and Fluid Warmer. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Quality IN Flow , Ltd. (Kibutz Einat, IL). The FDA issued a Cleared decision on April 27, 2018 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quality IN Flow , Ltd. devices

Submission Details

510(k) Number K180154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2018
Decision Date April 27, 2018
Days to Decision 98 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 128d · This submission: 98d
Pathway characteristics
Modification to existing cleared device.

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 K180154.
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K211800 · Quality IN Flow , Ltd. · Dec 2022