Cleared Traditional

K003513 - TAXOL ADMINISTRATION SET

K003513 is the FDA 510(k) clearance for TAXOL ADMINISTRATION 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 58-day FDA review.

K003513 · Icu Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
58d
Days
Class 2
Risk

K003513 is an FDA 510(k) clearance for the TAXOL ADMINISTRATION SET. 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 11, 2001 after a review of 58 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 K003513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2000
Decision Date January 11, 2001
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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 K003513.
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05
K011928 · Northgate Technologies, Inc. · Aug 2001
SURSHIELD WINGED INFUSION SET
K010103 · Terumo Medical Corp. · Mar 2001
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · Quest Medical, Inc. · Mar 2001
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · Baxter Healthcare Corp · Oct 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000
POSI-LINK
K000472 · Icu Medical, Inc. · May 2000