Cleared Abbreviated

K150304 - Oxyless Blood Tubing Set

K150304 is the FDA 510(k) clearance for Oxyless Blood Tubing Set by Oxyless, Ltd.. It is a Class 2 Gastroenterology & Urology device (product code FJK) cleared through the Abbreviated 510(k) pathway after a 383-day FDA review.

K150304 · Oxyless, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
383d
Days
Class 2
Risk

K150304 is an FDA 510(k) clearance for the Oxyless Blood Tubing Set. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Oxyless, Ltd. (London, GB). The FDA issued a Cleared decision on February 24, 2016 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Oxyless, Ltd. devices

Submission Details

510(k) Number K150304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2015
Decision Date February 24, 2016
Days to Decision 383 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
253d slower than avg
Panel avg: 130d · This submission: 383d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 42
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K150304.
SANSIN Tubing Sets for Hemodialysis
K202796 · Jiangxi Sanxin Medtec Co., Ltd. · Sep 2021
NovaLine Tubing Sets for Hemodialysis
K201866 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Mar 2021
Dimesol Tubing Sets for Hemodialysis
K171952 · Dimesol, Inc. · Mar 2018
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · Nipro Medical Corporation · Sep 2012
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc. · Feb 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
K080807 · Nxstage Medical, Inc. · Jul 2008