Cleared Special

K161832 - O2VENT T

K161832 is an FDA 510(k) clearance for O2VENT T, manufactured by Oventus Manufacturing Pty, Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 80-day FDA review.

K161832 · Oventus Manufacturing Pty, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
80d
Days
Class 2
Risk

K161832 is an FDA 510(k) clearance for the O2VENT T. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Oventus Manufacturing Pty, Ltd. (Indooroopilly, AU). The FDA issued a Cleared decision on September 23, 2016 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oventus Manufacturing Pty, Ltd. devices

FDA 510(k) Submission Details - K161832

510(k) Number K161832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date September 23, 2016
Days to Decision 80 days
Submission Type Special
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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 Consultant

Regulatory and Clinical Research Institute, Inc.
M.W. ANDY ANDERSON

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 - LRK Device, Anti-snoring

All 167
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