Cleared Special

K042182 - Y CLAVE CONNECTOR WITH INTEGRATED CHECK...

K042182 is the FDA 510(k) clearance for Y CLAVE CONNECTOR WITH INTEGRATED CHECK... by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Special 510(k) pathway after a 21-day FDA review.

K042182 · Icu Medical, Inc. · General Hospital
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Sep 2004
Decision
21d
Days
Class 2
Risk

K042182 is an FDA 510(k) clearance for the Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on September 1, 2004 after a review of 21 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 Icu Medical, Inc. devices

Submission Details

510(k) Number K042182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2004
Decision Date September 01, 2004
Days to Decision 21 days
Submission Type Special
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
108d faster than avg
Panel avg: 129d · This submission: 21d
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

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