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)
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.

View all Us Fusion, LLC. Dba Truecare Biomedix-USA devices

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 617
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K121554.
FLOWEASE [SUBCUTANEOUS] INFUSION SET
K121092 · Baxter Healthcare Corp · Jun 2012
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
K121634 · Baxter Healthcare Corporation · Jun 2012
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP
K121032 · Hospira, Inc. · Jun 2012
NEXUS TKO-6, LUER-ACTIVATED DEVICE
K113398 · Nexus Medical, LLC · Apr 2012
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
K113683 · Hospira, Inc. · Jan 2012
CYTOGUARD(TM) CLOSED LUER CONNECTOR
K112636 · B.Braun Medical, Inc. · Nov 2011