Cleared Traditional

K941190 - CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENS...

K941190 is the FDA 510(k) clearance for CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENS... by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K941190 · Icu Medical, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Jan 1995
Decision
323d
Days
Class 2
Risk

K941190 is an FDA 510(k) clearance for the CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET. 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 January 31, 1995 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K941190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date January 31, 1995
Days to Decision 323 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
194d slower than avg
Panel avg: 129d · This submission: 323d
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 K941190.
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BOLUS DISPENSER
K935811 · I-Flow Corp. · Jan 1995
VERSASAE PLASTIC CANNULA- 11 GAUGE
K945070 · Imed Corp. · Jan 1995
IV ADMINISTRATION SET FPA
K944208 · Medex, Inc. · Dec 1994