Cleared Special

K053129 - NEXUSTKO NEEDLELESS ACCESS DEVICE

K053129 is an FDA 510(k) clearance for NEXUSTKO NEEDLELESS ACCESS DEVICE, manufactured by Nexus Medical, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 30-day FDA review.

K053129 · Nexus Medical, LLC · General Hospital
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Dec 2005
Decision
30d
Days
Class 2
Risk

K053129 is an FDA 510(k) clearance for the NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5. 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 December 8, 2005 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nexus Medical, LLC devices

FDA 510(k) Submission Details - K053129

510(k) Number K053129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2005
Decision Date December 08, 2005
Days to Decision 30 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 513
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