Cleared Traditional

K854271 - ASA BLOOD TUBING LINES (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854271 · Organon Teknika Corp. · Gastroenterology & Urology device
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Nov 1985
Decision
13d
Days
Class 2
Risk

K854271 is an FDA 510(k) clearance for the ASA BLOOD TUBING LINES. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Oklahoma City, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K854271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1985
Decision Date November 05, 1985
Days to Decision 13 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 130d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 75
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K854271.
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K213992 · Fresenius Medical Care Renal Therapies Group, LLC · May 2023