Cleared Traditional

K200695 - MATRx plus

K200695 is an FDA 510(k) clearance for MATRx plus, manufactured by Zephyr Sleep Technologies. The device is a Class 2 Dental device with product code MNR cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K200695 · Zephyr Sleep Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
160d
Days
Class 2
Risk

K200695 is an FDA 510(k) clearance for the MATRx plus. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Zephyr Sleep Technologies (Calgary, CA). The FDA issued a Cleared decision on August 24, 2020 after a review of 160 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 868.2375 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Zephyr Sleep Technologies devices

FDA 510(k) Submission Details - K200695

510(k) Number K200695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2020
Decision Date August 24, 2020
Days to Decision 160 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 127d · This submission: 160d
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 Dental devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 109
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