Cleared Traditional

K180410 - Dosis SAM (FDA 510(k) Clearance)

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

K180410 · Dosis, Inc. · Gastroenterology & Urology device
Jan 2019
Decision
336d
Days
Class 2
Risk

K180410 is an FDA 510(k) clearance for the Dosis SAM. Classified as System, Hemodialysis, Access Recirculation Monitoring (product code MQS), Class II - Special Controls.

Submitted by Dosis, Inc. (Los Altos, US). The FDA issued a Cleared decision on January 16, 2019 after a review of 336 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 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K180410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2018
Decision Date January 16, 2019
Days to Decision 336 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 156d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQS System, Hemodialysis, Access Recirculation Monitoring
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.