Cleared Traditional

K250616 - Clave™ Neutral-Displacement Needlefree Connectors

K250616 is an FDA 510(k) clearance for Clave Neutral-Displacement Needlefree C..., manufactured by Icu Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K250616 · Icu Medical, Inc. · General Hospital
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Jun 2025
Decision
97d
Days
Class 2
Risk

K250616 is an FDA 510(k) clearance for the Clave™ Neutral-Displacement Needlefree Connectors. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on June 5, 2025 after a review of 97 days - within the typical 510(k) review window.

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 Icu Medical, Inc. devices

FDA 510(k) Submission Details - K250616

510(k) Number K250616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2025
Decision Date June 05, 2025
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 768
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