Cleared Traditional

K041861 - NEXUS INTRAVENOUS TUBING SETS (NIVTS)

K041861 is an FDA 510(k) clearance for NEXUS INTRAVENOUS TUBING SETS (NIVTS), manufactured by Nexus Medical, LLC. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K041861 · Nexus Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
140d
Days
Class 2
Risk

K041861 is an FDA 510(k) clearance for the NEXUS INTRAVENOUS TUBING SETS (NIVTS). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Nexus Medical, LLC (Lenexa, US). The FDA issued a Cleared decision on November 26, 2004 after a review of 140 days - within the typical 510(k) review window.

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 Nexus Medical, LLC devices

FDA 510(k) Submission Details - K041861

510(k) Number K041861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2004
Decision Date November 26, 2004
Days to Decision 140 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 129d · This submission: 140d
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 814
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K041861.
DRAGON HEART I.V. SET
K043235 · Dragon Heart Medical Devices Co., Ltd. · Mar 2005
F00010 - IV GRAVITY SETWITH MALE LUER SLIP
K042129 · Cedic S.R.L. · Jan 2005
LUTH-ALL SUB-Q NEEDLE SET
K042666 · Luth-All Medical Products, LLC · Dec 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936 · Baxter Healthcare Corp · Nov 2004
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
K041490 · B.Braun Medical, Inc. · Oct 2004
IV ADMINISTRATION SET B400 SP
K042693 · Codan US Corp. · Oct 2004