Cleared Traditional

K171215 - QiF Blood and Fluid Warmer

K171215 is an FDA 510(k) clearance for QiF Blood and Fluid Warmer, manufactured by Quality IN Flow , Ltd.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K171215 · Quality IN Flow , Ltd. · General Hospital
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Sep 2017
Decision
155d
Days
Class 2
Risk

K171215 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 September 27, 2017 after a review of 155 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Quality IN Flow , Ltd. devices

FDA 510(k) Submission Details - K171215

510(k) Number K171215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2017
Decision Date September 27, 2017
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
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 Consultant

Hogan Lovells US LLP
John Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 64
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K171215.
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