Cleared Traditional

K161624 - MicrO2 OSA Device with Micro-Recorder

K161624 is an FDA 510(k) clearance for MicrO2 OSA Device with Micro-Recorder, manufactured by Microdental, Inc.. The device is a Class 2 Dental device with product code PLC cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K161624 · Microdental, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
147d
Days
Class 2
Risk

K161624 is an FDA 510(k) clearance for the MicrO2 OSA Device with Micro-Recorder. Classified as Sleep Appliances With Patient Monitoring (product code PLC), Class II - Special Controls.

Submitted by Microdental, Inc. (Dublin, US). The FDA issued a Cleared decision on November 7, 2016 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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.

FDA 510(k) Submission Details - K161624

510(k) Number K161624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2016
Decision Date November 07, 2016
Days to Decision 147 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
19d slower than avg
Panel avg: 128d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLC Device Classification - Class 2, Special Controls

Product Code PLC Sleep Appliances With Patient Monitoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
Definition For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy.
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 - PLC Sleep Appliances With Patient Monitoring

All 9
Devices cleared under the same product code (PLC) and FDA review panel - the closest regulatory comparables to K161624.
OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
K181571 · Mark Abramson, D.D.S., Inc. · Apr 2019
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
K172859 · Prosomnous Sleep Technologies · Nov 2017
Acrylic Herbst Appliance with Micro-Recorder
K170606 · Gergen'S Orthodontic Lab · Nov 2017
TAP 3, TAP 1
K160239 · Airway Management, Inc. · Aug 2016
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
K150369 · Somnomed, Inc. · Jun 2015