Cleared Traditional

K941190 - CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET

K941190 is an FDA 510(k) clearance for CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENS..., 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 323-day FDA review.

K941190 · Icu Medical, Inc. · General Hospital
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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

FDA 510(k) Submission Details - K941190

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.

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 772
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K941190.
VENTED/NON-VENTED GEMINI ADMINISTRATION SET
K944320 · Imed Corp. · Feb 1995
NU-SITE
K943897 · Medex, Inc. · Feb 1995
IV BAG PUMP
K940657 · I-Flow Corp. · Feb 1995
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