Cleared Traditional

K003854 - INTRAVASCULAR ADMINISTRATION SET

K003854 is an FDA 510(k) clearance for INTRAVASCULAR ADMINISTRATION SET, manufactured by Infusion Devices, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K003854 · Infusion Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
54d
Days
Class 2
Risk

K003854 is an FDA 510(k) clearance for the INTRAVASCULAR ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Infusion Devices, Inc. (Mccordsville, US). The FDA issued a Cleared decision on February 5, 2001 after a review of 54 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.

FDA 510(k) Submission Details - K003854

510(k) Number K003854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2000
Decision Date February 05, 2001
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 1172
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K003854.
SWABSITE SWABBABLE VALVE, MODEL 245000
K002689 · Quest Medical, Inc. · Mar 2001
DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET
K003977 · Disetronic Medical Systems AG · Feb 2001
INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET
K001329 · Lifemed of California · Feb 2001
TAXOL ADMINISTRATION SET
K003513 · Icu Medical, Inc. · Jan 2001
BIOTEQ I.V. (INTRAVENOUS) SET
K002449 · Bioteque Corp. · Dec 2000
ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S
K001233 · R-Group Intl. · Dec 2000
K003854 · INTRAVASCULAR ADMINISTRATION SET
Download PDF FDA Summary Infusion Devices, Inc.