Cleared Traditional

K121554 - Q-FLO CLOSED MALE LUER CONNECTOR

K121554 is an FDA 510(k) clearance for Q-FLO CLOSED MALE LUER CONNECTOR, manufactured by Us Fusion, LLC. Dba Truecare Biomedix-USA. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K121554 · Us Fusion, LLC. Dba Truecare Biomedix-USA · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
14d
Days
Class 2
Risk

K121554 is an FDA 510(k) clearance for the Q-FLO CLOSED MALE LUER CONNECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Us Fusion, LLC. Dba Truecare Biomedix-USA (South Miami, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 14 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K121554

510(k) Number K121554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2012
Decision Date June 08, 2012
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 1062
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K121554.
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K121554 · Q-FLO CLOSED MALE LUER CONNECTOR
Download PDF FDA Summary Us Fusion, LLC. Dba T…