Cleared Special

MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR (K041179) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041179 · Medegen Medical Manufacturing Services, Inc. · General Hospital
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Jun 2004
Decision
29d
Days
Class 2
Risk

K041179 is an FDA 510(k) clearance for the MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medegen Medical Manufacturing Services, Inc. (Ontario, US). The FDA issued a Cleared decision on June 4, 2004 after a review of 29 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 Medegen Medical Manufacturing Services, Inc. devices

Submission Details

510(k) Number K041179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2004
Decision Date June 04, 2004
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 208
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