Cleared Traditional

K040069 - DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR

K040069 is an FDA 510(k) clearance for DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR, manufactured by Dymedix, Inc.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K040069 · Dymedix, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K040069

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 140d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Citech
ROBERT MOSENKIS

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 - MNR Ventilatory Effort Recorder

All 164
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K040069.
MICROMESAM BASIC-SET
K040576 · Map Medizintechnik Fur Arzt Und Patient GmbH · Jul 2004
PORTABLE SLEEP DATA RECORDER (PSDR)
K033402 · Pro-Tech Services, Inc. · Jun 2004
STARDUST II, MODEL 1011176
K021845 · Respironics, Inc. · May 2004
COMPUMEDICS SUMMIT IP
K040194 · Compumedics USA, Ltd. · Apr 2004
EMBLA N7000
K024322 · Medcare Flaga · Oct 2003
APLAB, MODEL 801D0030
K030379 · Sector Medical Corp. · Aug 2003
K040069 · DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
Download PDF FDA Summary Dymedix, Inc.