Cleared Traditional

K033290 - TALON INFUSION SET

K033290 is the FDA 510(k) clearance for TALON INFUSION SET by Icu Medical, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K033290 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
181d
Days
Class 2
Risk

K033290 is an FDA 510(k) clearance for the TALON INFUSION SET, MODEL IP XXXX. 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 April 12, 2004 after a review of 181 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 K033290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2003
Decision Date April 12, 2004
Days to Decision 181 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
52d slower than avg
Panel avg: 129d · This submission: 181d
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 K033290.
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
K040710 · Icu Medical, Inc. · Aug 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410 · Icu Medical, Inc. · Jul 2004
SPLIT SEPTUM INJECTION SITES
K041042 · Fresenius Medical Care North America · Jul 2004
MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900
K040385 · Quest Medical, Inc. · Apr 2004
CLC2000 CATHETER PATENCY DEVICE
K021692 · Icu Medical, Inc. · Dec 2003
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
K033576 · Abbott Laboratories · Dec 2003