Cleared Special

K080321 - SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM

K080321 is an FDA 510(k) clearance for SNAP MODEL 7 SNORING AND APNEA RECORDIN..., manufactured by Snap Laboratories, LLC. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Special 510(k) pathway after a 107-day FDA review.

K080321 · Snap Laboratories, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
107d
Days
Class 2
Risk

K080321 is an FDA 510(k) clearance for the SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Snap Laboratories, LLC (Wheeling, US). The FDA issued a Cleared decision on May 23, 2008 after a review of 107 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080321

510(k) Number K080321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2008
Decision Date May 23, 2008
Days to Decision 107 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 162
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