Cleared Traditional

K162951 - TUBETECH IV Administration Set

K162951 is an FDA 510(k) clearance for TUBETECH IV Administration Set, manufactured by Douglas Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K162951 · Douglas Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
277d
Days
Class 2
Risk

K162951 is an FDA 510(k) clearance for the TUBETECH IV Administration Set. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Douglas Medical Products, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 28, 2017 after a review of 277 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 Douglas Medical Products, Inc. devices

FDA 510(k) Submission Details - K162951

510(k) Number K162951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date July 28, 2017
Days to Decision 277 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 129d · This submission: 277d
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 572
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K162951.
IV Administration Sets
K170595 · B.Braun Medical, Inc. · Nov 2017
IV Fat Emulsion Administration Sets
K172544 · Baxter Healthcare Corporation · Sep 2017
Medline Blood Collection Set
K170002 · Medline Industries, Inc. · Sep 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808 · Baxter Healthcare Corporation · Jun 2017
Q2 Low Pressure Power Injection Extension Set
K162804 · Quest Medical, Inc. · Mar 2017
Hospira Extension Set, Hospira Primary Set
K161036 · Hospira, Inc. · Jan 2017