MNR · Ventilatory Effort Recorder
Anesthesiology · 21 CFR 868.2375 · Class 2
Overview
| Product Code | MNR |
|---|---|
| Device Name | Ventilatory Effort Recorder |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 160)
Showing 20 most recent of 160 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252497 | SANSA HSAT | Huxley Medical | Dec 10, 2025 | SESE |
| K250882 | SANSA HSAT | Huxley Medical | Oct 29, 2025 | SESE |
| K250460 | WatchPAT400 (WP400) | Itamar Medical , Ltd. | Sep 5, 2025 | SESE |
| K252383 | Somfit D | Compumedics Limited | Aug 28, 2025 | SESE |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | Jul 3, 2025 | SESE |
| K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | Jun 18, 2025 | SESE |
| K243092 | AcuPebble Ox (200) | Acurable Limited | Mar 19, 2025 | SESE |
| K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | Feb 3, 2025 | SESE |
| K244027 | SANSA HSAT | Huxley Medical | Jan 28, 2025 | SESE |
| K242290 | DormoTech NLab | Dormotech Medical, Ltd. | Jan 8, 2025 | SESE |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | Dec 18, 2024 | SESE |
| K231667 | Withings Sleep Rx | Withings | Sep 6, 2024 | SESE |
| K233501 | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. | Jul 26, 2024 | SESE |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | Jul 15, 2024 | SESE |
| K240100 | SAM Model 9-10000 | Snap Diagnostics, LLC | Jun 4, 2024 | SESE |
| K231355 | Aurora | Ensodata | Feb 9, 2024 | SESE |
| K231546 | Somfit | Compumedics Limited | Nov 30, 2023 | SESE |
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | Aug 18, 2023 | SESE |
| K221816 | Wesper Lab | Wesper, Inc. | Mar 9, 2023 | SESE |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | Feb 23, 2023 | SESE |
Top Applicants
- Itamar Medical , Ltd. — 10 clearances
- Snap Laboratories, LLC — 6 clearances
- Respironics, Inc. — 6 clearances
- Resmed Germany, Inc. — 5 clearances
- Advanced Brain Monitoring, Inc. — 5 clearances
