Cleared Traditional

K181571 - OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor

K181571 is an FDA 510(k) clearance for OASYS Oral/Nasal Airway System and OASY..., manufactured by Mark Abramson, D.D.S., Inc.. The device is a Class 2 Dental device with product code PLC cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K181571 · Mark Abramson, D.D.S., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
309d
Days
Class 2
Risk

K181571 is an FDA 510(k) clearance for the OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor. Classified as Sleep Appliances With Patient Monitoring (product code PLC), Class II - Special Controls.

Submitted by Mark Abramson, D.D.S., Inc. (Redwood City, US). The FDA issued a Cleared decision on April 19, 2019 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mark Abramson, D.D.S., Inc. devices

FDA 510(k) Submission Details - K181571

510(k) Number K181571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2018
Decision Date April 19, 2019
Days to Decision 309 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
181d slower than avg
Panel avg: 128d · This submission: 309d
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 Consultant

Fishermed Consulting, LLC
Cheryl Fisher

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 - 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 K181571.
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
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K190353 · Residential Home Sleep Services · Apr 2020
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
MicrO2 OSA Device with Micro-Recorder
K161624 · Microdental, Inc. · Nov 2016