MNR
- Product code
- MNR
- Device name
- Ventilatory Effort Recorder
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.2375
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 21
- Summaries archived here
- 20 (direct download)
- 510(k) clearances (all years, FDA)
- 164 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (21)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254042 | 2026-07-31 | Itamar Medical , Ltd. | WatchPAT SW | |
| K260050 | 2026-07-15 | Huneo, LLC | WRAP System | |
| K253148 | 2026-06-22 | Vivaquant, Inc. Dba Rhythm Express | RX-1 Sleep | |
| K252628 | 2026-04-27 | Wesper, Inc. | CASSIE | |
| K252497 | 2025-12-10 | Huxley Medical | SANSA HSAT | |
| K250882 | 2025-10-29 | Huxley Medical | SANSA HSAT | |
| K250460 | 2025-09-05 | Itamar Medical , Ltd. | WatchPAT400 (WP400) | |
| K252383 | 2025-08-28 | Compumedics Limited | Somfit D | |
| K243220 | 2025-07-03 | Onera B.V. | Onera STS 2 (ONERA STS 2) | |
| K242224 | 2025-06-18 | Happy Health, Inc. | Happy Health Home Sleep Test | |
| K243092 | 2025-03-19 | Acurable Limited | AcuPebble Ox (200) | |
| K243268 | 2025-02-03 | Pranaq Pte. , Ltd. | TipTraQ (TTQ001) | |
| K244027 | 2025-01-28 | Huxley Medical | SANSA HSAT | |
| K242290 | 2025-01-08 | Dormotech Medical, Ltd. | DormoTech NLab | |
| K242424 | 2024-12-18 | Cadwell Industries, Inc. | Bluebird Single-Use Respiratory Effort Belt | |
| K231667 | 2024-09-06 | Withings | Withings Sleep Rx | |
| K233501 | 2024-07-26 | Largan Medical Co., Ltd. | LARGAN Health AI-Tech Sleep Apnea and Sleep Qualit… | FDA |
| K240285 | 2024-07-15 | Huxley Medical | Huxley SANSA Home Sleep Apnea Test (1000-00) | |
| K240100 | 2024-06-04 | Snap Diagnostics, LLC | SAM Model 9-10000 | |
| K231355 | 2024-02-09 | Ensodata | Aurora | |
| K231546 | 2023-11-30 | Compumedics Limited | Somfit |
Official FDA classification page: MNR
Classification and pathway per current FDA publications. Data from openFDA (CC0).