Cleared Traditional

K040069 - DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR (FDA 510(k) Clearance)

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

K040069 · Dymedix, Inc. · Anesthesiology device
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May 2004
Decision
112d
Days
Class 2
Risk

K040069 is an FDA 510(k) clearance for the DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Dymedix, Inc. (Stoughton, US). The FDA issued a Cleared decision on May 5, 2004 after a review of 112 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, Inc. devices

Submission Details

510(k) Number K040069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2004
Decision Date May 05, 2004
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 139d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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.