Cleared Traditional

K915571 - CLAVE CONNECTOR

K915571 is the FDA 510(k) clearance for CLAVE CONNECTOR by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K915571 · Icu Medical, Inc. · General Hospital
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Sep 1992
Decision
284d
Days
Class 2
Risk

K915571 is an FDA 510(k) clearance for the CLAVE CONNECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 21, 1992 after a review of 284 days - an extended review cycle.

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

Submission Details

510(k) Number K915571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1991
Decision Date September 21, 1992
Days to Decision 284 days
Submission Type Traditional
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
155d slower than avg
Panel avg: 129d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 445
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K915571.
LIFESHIELD ANESTHESIA SET
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K921674 · Strato Medical Corp. · Sep 1992
MERIT ADMINISTRATION SET
K915678 · Merit Medical Systems, Inc. · Jul 1992
CONTINU-FLO(R) SOLUTION SET
K921703 · Baxter Healthcare Corp · Jun 1992
INJECTION SITE WITH LUER LOCK
K915828 · Baxter Healthcare Corp · May 1992