Cleared Traditional

Clave? Neutral-Displacement Needlefree Connectors

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

About This 510(k) Submission

K250616 is an FDA 510(k) clearance for the Clave? Neutral-Displacement Needlefree Connectors, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Icu Medical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on June 5, 2025, 97 days after receiving the submission on February 28, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K250616 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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