Cleared Traditional

K060074 - INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326

K060074 is an FDA 510(k) clearance for INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K060074 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
78d
Days
Class 2
Risk

K060074 is an FDA 510(k) clearance for the INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 78 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K060074

510(k) Number K060074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2006
Decision Date March 29, 2006
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 791
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K060074.
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
K060352 · Health Line International Corporation · May 2006
TIANJIN MEDIS DISPOSABLE INFUSION SET
K060082 · Tianjin Medis International Trade Co., Ltd. · Mar 2006
ONE STICK Y EXTENSION SET AND VOLUMETER
K060672 · One Stick, LLC · Mar 2006
ALARIS SAFETY MALE LUER
K053049 · Cardinal Health, Alaris Products · Jan 2006
TEGO, MODEL D1000
K053106 · Icu Medical, Inc. · Jan 2006
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
K052887 · Terumo Europe N.V. · Dec 2005