Cleared Traditional

K200654 - Rubicon SA System

K200654 is an FDA 510(k) clearance for Rubicon SA System, manufactured by Dymedix Diagnostics, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K200654 · Dymedix Diagnostics, Inc. · Anesthesiology device
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Jul 2020
Decision
132d
Days
Class 2
Risk

K200654 is an FDA 510(k) clearance for the Rubicon SA System. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Dymedix Diagnostics, Inc. (Shoreview, US). The FDA issued a Cleared decision on July 22, 2020 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dymedix Diagnostics, Inc. devices

FDA 510(k) Submission Details - K200654

510(k) Number K200654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2020
Decision Date July 22, 2020
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 140d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Dymedix Diagnostics, Inc. C/O Promedic, LLC
Paul Dryden

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.

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