Cleared Abbreviated

K150304 - Oxyless Blood Tubing Set

K150304 is an FDA 510(k) clearance for Oxyless Blood Tubing Set, manufactured by Oxyless, Ltd.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K150304

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 131d · This submission: 383d
Pathway characteristics
Standards-based clearance path.

FJK Device Classification - Class 2, Special Controls

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 Consultant

Bob Duffy Associates
Bob Duffy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 59
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K150304.
NovaLine Tubing Sets for Hemodialysis
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Dimesol Tubing Sets for Hemodialysis
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K161582 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Jun 2017
TABLO CARTRIDGE
K140841 · Home Dialysis Plus · Sep 2014
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · Nipro Medical Corporation · Sep 2012
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
K120823 · Fresenius Medical Care North America, Design Cente · Jun 2012