Cleared Traditional

K190353 - Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

K190353 is an FDA 510(k) clearance for Bfit Sleep, manufactured by Residential Home Sleep Services. The device is a Class 2 Dental device with product code PLC cleared through the Traditional 510(k) pathway after a 420-day FDA review.

K190353 · Residential Home Sleep Services · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
420d
Days
Class 2
Risk

K190353 is an FDA 510(k) clearance for the Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac. Classified as Sleep Appliances With Patient Monitoring (product code PLC), Class II - Special Controls.

Submitted by Residential Home Sleep Services (Battle Creek, US). The FDA issued a Cleared decision on April 10, 2020 after a review of 420 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Residential Home Sleep Services devices

FDA 510(k) Submission Details - K190353

510(k) Number K190353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2019
Decision Date April 10, 2020
Days to Decision 420 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
292d slower than avg
Panel avg: 128d · This submission: 420d
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 K190353.
iNOS intraoral biosensor
K254304 · Achaemenid, LLC · Aug 2026
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
K252765 · Prosomnus Sleep Technologies · Apr 2026
Rest Assure System
K233497 · Somnomed, Inc. · Oct 2024
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