Cleared Traditional

K173064 - ZAPnea Oral Appliance (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173064 · B. Fareid, Dds, PC · Dental device
Mar 2019
Decision
525d
Days
Class 2
Risk

K173064 is an FDA 510(k) clearance for the ZAPnea Oral Appliance. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by B. Fareid, Dds, PC (Kingsburg, US). The FDA issued a Cleared decision on March 8, 2019 after a review of 525 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.

Submission Details

510(k) Number K173064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date March 08, 2019
Days to Decision 525 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
367d slower than avg
Panel avg: 158d · This submission: 525d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - LRK Device, Anti-snoring

All 19
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K173064.
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
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QuietLab Pro
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Hushd Avera
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AIO Breathe
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