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SnoreSounds Ventilatory Effort Recorder

by Appian Medical, Inc.

510(k) K150102

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150102 Date5 Nov 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
SnoreSounds
510(k) Number
FDA Product Code
MNR
Device Class
Class II
Regulation
21 CFR Part 868.2375
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SnoreSounds is a ventilatory effort recorder, a diagnostic device designed to monitor and analyze respiratory effort during sleep. It employs a smartphone application and proprietary algorithms to detect and assess patterns associated with obstructive sleep apnea (OSA) by analyzing snore recordings. This device aids in identifying potential sleep-related breathing disorders through continuous, non-invasive monitoring.

The SnoreSounds is supplied as a software application for smartphones, intended for single-use diagnostic evaluation. It is classified as a Class II medical device under FDA regulation 868.2375 and has received FDA 510(k) clearance (K150102) as substantially equivalent to a predicate device. The device operates within the specialty of anesthesiology and is not intended for MRI use. No sterility or reusable specifications are indicated.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SnoreSounds ventilatory effort recorder used for?

    The SnoreSounds is designed to monitor and analyze respiratory effort during sleep by recording and analyzing snore patterns. It helps identify potential obstructive sleep apnea (OSA) through continuous, non-invasive monitoring, assisting clinicians in diagnosing sleep-related breathing disorders.

  • How is the SnoreSounds supplied and intended for use?

    The SnoreSounds is supplied exclusively as a software application for smartphones. It is intended for single-use diagnostic evaluations, meaning each use is for one patient assessment before the data is cleared or the app is reset.

  • Is the SnoreSounds device sterile or reusable?

    The SnoreSounds is not a physical medical device requiring sterility or reuse. It operates solely through a smartphone application, so there are no reusable components or sterility considerations—it is a digital diagnostic tool.

  • What regulatory approval does the SnoreSounds hold?

    The SnoreSounds has received FDA 510(k) clearance (K150102) as substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulation 868.2375, specifically for ventilatory effort recorders.

  • Can the SnoreSounds be used in an MRI environment?

    No, the SnoreSounds is not intended for use in an MRI environment. Its design and functionality are limited to non-invasive sleep monitoring via smartphone, with no compatibility or safety assurances for MRI settings.