Cleared Traditional

K974589 - SMARTVALVE

K974589 is the FDA 510(k) clearance for SMARTVALVE by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K974589 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
31d
Days
Class 2
Risk

K974589 is an FDA 510(k) clearance for the SMARTVALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icu Medical, Inc. devices

Submission Details

510(k) Number K974589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1997
Decision Date January 09, 1998
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 K974589.
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
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DUAL LUER LOCK CAP
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MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163 · Medtronic Minimed · Feb 1998
V3 VALVE
K974145 · B.Braun Medical, Inc. · Jan 1998
POSITIVE PRESSURE CONNECTOR
K973167 · Icu Medical, Inc. · Nov 1997
CORE RESISTANT HUBER INFUSION SETS
K972712 · Icu Medical, Inc. · Oct 1997