Cleared Special

K110064 - SNAP MODEL 8 SNORING AND APNEA RECORDIN...

K110064 is an FDA 510(k) clearance for SNAP MODEL 8 SNORING AND APNEA RECORDIN..., manufactured by Snap Diagnostics, LLC. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Special 510(k) pathway after a 67-day FDA review.

K110064 · Snap Diagnostics, LLC · Anesthesiology device
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Mar 2011
Decision
67d
Days
Class 2
Risk

K110064 is an FDA 510(k) clearance for the SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Snap Diagnostics, LLC (Wheeling, US). The FDA issued a Cleared decision on March 18, 2011 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Snap Diagnostics, LLC devices

FDA 510(k) Submission Details - K110064

510(k) Number K110064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2011
Decision Date March 18, 2011
Days to Decision 67 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 140d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 63
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