Cleared Abbreviated

K103704 - REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP

K103704 is an FDA 510(k) clearance for REMOTELY CONTROLLED MANDIBULAR POSITIONER, manufactured by Zephyr Sleep Technologies, Inc.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 459-day FDA review.

K103704 · Zephyr Sleep Technologies, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
459d
Days
Class 2
Risk

K103704 is an FDA 510(k) clearance for the REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Zephyr Sleep Technologies, Inc. (Calgary; Alberta, CA). The FDA issued a Cleared decision on March 23, 2012 after a review of 459 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. 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 Zephyr Sleep Technologies, Inc. devices

FDA 510(k) Submission Details - K103704

510(k) Number K103704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2010
Decision Date March 23, 2012
Days to Decision 459 days
Submission Type Abbreviated
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
332d slower than avg
Panel avg: 127d · This submission: 459d
Pathway characteristics
Standards-based clearance path.

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 Peers - LRK Device, Anti-snoring

All 167
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