Cleared Traditional

K113398 - NEXUS TKO-6, LUER-ACTIVATED DEVICE

K113398 is an FDA 510(k) clearance for NEXUS TKO-6, manufactured by Nexus Medical, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K113398 · Nexus Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
153d
Days
Class 2
Risk

K113398 is an FDA 510(k) clearance for the NEXUS TKO-6, LUER-ACTIVATED DEVICE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Nexus Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on April 18, 2012 after a review of 153 days - an extended review 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: 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 Nexus Medical, LLC devices

FDA 510(k) Submission Details - K113398

510(k) Number K113398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2011
Decision Date April 18, 2012
Days to Decision 153 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 129d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 815
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K113398.
HLIC NEEDLE-LESS VALVE
K120548 · Health Line International Corporation · May 2012
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
K120261 · Perouse Medical · May 2012
ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
K120872 · Unomedical A/S Infusion Devices · Apr 2012
INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
K112073 · Rx Devices, LLC · Apr 2012
ARISURE NEUTRAL VALVE
K120799 · Yukon Medical, LLC · Mar 2012
LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
K113683 · Hospira, Inc. · Jan 2012