Cleared Traditional

K180410 - Dosis SAM

K180410 is an FDA 510(k) clearance for Dosis SAM, manufactured by Dosis, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MQS cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K180410 · Dosis, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Dosis, Inc. devices

FDA 510(k) Submission Details - K180410

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 131d · This submission: 336d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQS Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Smith Assoicates
E.J. Smith

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 - MQS System, Hemodialysis, Access Recirculation Monitoring

All 17
Devices cleared under the same product code (MQS) and FDA review panel - the closest regulatory comparables to K180410.
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