Product code MNR— Anesthesiology
APNEA RISK EVALUATION SYSTEM (ARES)
- Classification name
- Ventilatory Effort Recorder
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Total cleared
- 164
- First cleared
- Most recent
Market context for product code MNR
FDA has cleared devices under product code MNR between 1995 and 2026, filed by 88 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code MNR
Recent clearances under product code MNR
1–100 of 164- K254042 — WatchPAT SW
- K260050 — WRAP System
- K253148 — RX-1 Sleep
- K252628 — CASSIE
- K252497 — SANSA HSAT
- K250882 — SANSA HSAT
- K250460 — WatchPAT400 (WP400)
- K252383 — Somfit D
- K243220 — Onera STS 2 (ONERA STS 2)
- K242224 — Happy Health Home Sleep Test
- K243092 — AcuPebble Ox (200)
- K243268 — TipTraQ (TTQ001)
- K244027 — SANSA HSAT
- K242290 — DormoTech NLab
- K242424 — Bluebird Single-Use Respiratory Effort Belt
- K231667 — Withings Sleep Rx
- K233501 — LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
- K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00)
- K240100 — SAM Model 9-10000
- K231355 — Aurora
- K231546 — Somfit
- K223573 — Onera Sleep Test System (Onera STS)
- K221816 — Wesper Lab
- K222579 — Belun Sleep System BLS-100
- K222950 — AcuPebble OX100
- K223675 — WatchPAT ONE (WP1)
- K220012 — BresoDX1
- K222331 — WatchPAT300 (WP300)
- K220095 — ANNE Sleep
- K213360 — SleepCheckRx
- K210593 — Onera Sleep Test System (Onera STS)
- K203839 — WatchPAT200U (WP200U)
- K220028 — NightOwl
- K203343 — Wesper Lab
- K213463 — NightOwl
- K210480 — AcuPebble SA
- K201495 — Maxxi Flow Sensor
- K200695 — MATRx plus
- K200654 — Rubicon SA System
- K191031 — NightOwl
- K191095 — Maxxi Snore Sensor
- K191925 — MATRx Plus
- K183625 — SomnaPatch
- K180001 — Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
- K182618 — SleepImage System
- K173974 — DROWZLE
- K171304 — Maxxi Rip Sensor
- K183559 — WatchPAT ONE
- K173793 — XactTrace Single Use Respiratory Effort Belt System
- K181996 — MATRx Plus
- K180775 — Watch-PAT300
- K172799 — Positional Sleep Assessment System (PoSAS) software
- K163696 — SleepImage System
- K163665 — MATRx plus
- K160499 — Apnea Risk Evaluation System (ARES), Model 620
- K161579 — Watch-PAT200U
- K153070 — Watch-PAT200U
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- K151433 — AUDICOR CA300/CC100 Analyzer with SDB
- K151361 — Nox RIP Belts & Cables
- K150102 — SnoreSounds
- K143272 — ApneaLink Air
- K140861 — SOMNOTOUCH RESP
- K133859 — WATCH-PAT200U (WP200U)
- K131883 — AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
- K131932 — APNEALINK PRO
- K131994 — SOMNOLYZER 24X7
- K124062 — QDC-PRO, AND NOX-RIP
- K122516 — EMBLETTA MPR
- K112514 — APNEA RISK EVALUATION SYSTEM (ARES)
- K112822 — SLEEPSTRIP II
- K112102 — MICHELE SLEEP SCORING SYSTEMS
- K111314 — MORPHEUS OX
- K111742 — MDRIVE
- K110486 — ACCUSOM
- K111194 — APNEA RISK EVALUATION SYSTEM (ARES)
- K102567 — WATCH-PAT 200S-3 (WP200S-3)
- K110705 — APNEA RISK EVALUATION SYSTEM (ARES)
- K110064 — SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
- K092003 — CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
- K090484 — ALICE PDX
- K090958 — INOMAX DS (DELIVERY SYSTEM)
- K082853 — CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
- K083575 — APNEALINK PLUS, MODEL: 22328
- K083620 — SOMNOLYZER 24X7
- K083874 — GALAXY
- K082968 — APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
- K081861 — HOLTER LX ANALYSIS
- K082113 — NOX T3, NOXTURNAL (PC APPLICATION)
- K081485 — SOMNOWATCH
- K080375 — RMX PHYSIOLOGICAL DATA RECORDER
- K081982 — WATCH-PAT 200S-2 (WP200S-2)
- K073682 — EMBLETTA GOLD
- K080983 — PROVENT NASAL CANNULA
- K081176 — FLOCHANNEL
- K081037 — WATCH-PAT 200I (WP200I)
- K080321 — SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
- K080427 — WATCH-PAT MODEL 100S-2
- K073269 — HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
- K072201 — COMPUMEDICS SOMTE PSG RECORDING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.