Cleared Traditional

Liebel-Flarsheim IBP Transfer Set (K193010) - FDA 510(k) Clearance

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

K193010 · Liebel-Flarsheim Company, LLC · General Hospital
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Nov 2020
Decision
386d
Days
Class 2
Risk

K193010 is an FDA 510(k) clearance for the Liebel-Flarsheim IBP Transfer Set. Classified as Iodinated Contrast Media Transfer Tubing Set (product code PQH), Class II - Special Controls.

Submitted by Liebel-Flarsheim Company, LLC (Richmond Heights, US). The FDA issued a Cleared decision on November 18, 2020 after a review of 386 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Elevated predicate reliance profile. 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 Liebel-Flarsheim Company, LLC devices

Submission Details

510(k) Number K193010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2019
Decision Date November 18, 2020
Days to Decision 386 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 129d · This submission: 386d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PQH Iodinated Contrast Media Transfer Tubing Set
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition The Iodinated Contrast Media Transfer Set Is Intended To Transfer Iodinated Contrast Media From Imaging Bulk Package Contrast Media In A Controlled Ambient Environment. The Transfer Set Is Intended To Be Used To Directly Fill Multiple Sterile Single Use Syringes From An Imaging Bulk Package Contrast Media Bulk Package Under Controlled Ambient Filling Conditions Such As A Ct Suite.
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

Guerbet, LLC
Matthew Helmi

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.