MNR · Class II · 21 CFR 868.2375

FDA Product Code MNR: Ventilatory Effort Recorder

Leading manufacturers include Respironics, Inc., Itamar Medical , Ltd. and Huxley Medical.

164
Total
164
Cleared
200d
Avg days
1995
Since
Growing category - 16 submissions in the last 2 years vs 12 in the prior period
Consistent review times: 197d avg (recent)

FDA 510(k) Cleared Ventilatory Effort Recorder Devices (Product Code MNR)

164 devices
1–24 of 164
Cleared Apr 27, 2026
CASSIE
K252628
Wesper, Inc.
Anesthesiology · 250d
Cleared Dec 10, 2025
SANSA HSAT
K252497
Huxley Medical
Anesthesiology · 124d
Cleared Oct 29, 2025
SANSA HSAT
K250882
Huxley Medical
Cardiovascular · 219d
Cleared Sep 05, 2025
WatchPAT400 (WP400)
K250460
Itamar Medical , Ltd.
Anesthesiology · 199d
Cleared Aug 28, 2025
Somfit D
K252383
Compumedics Limited
Neurology · 28d
Cleared Jul 03, 2025
Onera STS 2 (ONERA STS 2)
K243220
Onera B.V.
Neurology · 269d
Cleared Jun 18, 2025
Happy Health Home Sleep Test
K242224
Happy Health, Inc.
Anesthesiology · 324d
Cleared Mar 19, 2025
AcuPebble Ox (200)
K243092
Acurable Limited
Anesthesiology · 170d
Cleared Feb 03, 2025
TipTraQ (TTQ001)
K243268
Pranaq Pte. , Ltd.
Anesthesiology · 111d
Cleared Jan 28, 2025
SANSA HSAT
K244027
Huxley Medical
Anesthesiology · 29d
Cleared Jan 08, 2025
DormoTech NLab
K242290
Dormotech Medical, Ltd.
Neurology · 159d
Cleared Dec 18, 2024
Bluebird Single-Use Respiratory Effort Belt
K242424
Cadwell Industries, Inc.
Anesthesiology · 125d
Cleared Sep 06, 2024
Withings Sleep Rx
K231667
Withings
Anesthesiology · 457d
Cleared Jul 26, 2024
“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)
K233501
Largan Medical Co., Ltd.
Anesthesiology · 269d
Cleared Jul 15, 2024
Huxley SANSA Home Sleep Apnea Test (1000-00)
K240285
Huxley Medical
Anesthesiology · 165d
Cleared Jun 04, 2024
SAM Model 9-10000
K240100
Snap Diagnostics, LLC
Anesthesiology · 144d
Cleared Feb 09, 2024
Aurora
K231355
Ensodata
Anesthesiology · 275d
Cleared Nov 30, 2023
Somfit
K231546
Compumedics Limited
Neurology · 184d
Cleared Aug 18, 2023
Onera Sleep Test System (Onera STS)
K223573
Onera B.V.
Neurology · 261d
Cleared Mar 09, 2023
Wesper Lab
K221816
Wesper, Inc.
Anesthesiology · 260d
Cleared Feb 23, 2023
Belun Sleep System BLS-100
K222579
Belun Technology Company Limited
Anesthesiology · 182d
Cleared Feb 03, 2023
AcuPebble OX100
K222950
Acurable Limited
Anesthesiology · 129d
Cleared Jan 06, 2023
WatchPAT ONE (WP1)
K223675
Itamar Medical , Ltd.
Anesthesiology · 30d
Cleared Dec 21, 2022
BresoDX1
K220012
Bresotec, Inc.
Anesthesiology · 351d

About Product Code MNR - Regulatory Context

510(k) Submission Activity

164 total 510(k) submissions under product code MNR since 1995, with 164 receiving FDA clearance (average review time: 200 days).

Submission volume has increased in recent years - 16 submissions in the last 24 months compared to 12 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MNR Product Code

FDA review times for MNR submissions have been consistent, averaging 197 days recently vs 201 days historically.

MNR devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →