Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MNR — Predicate Candidate Screening
164 FDA 510(k) clearances under this product code; the 50 most recent screened below.
170 daysmedian FDA review time
358 days90th percentile
164clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254042 | WatchPAT SW | Itamar Medical , Ltd. | 2026-07-31 | 227 | 0 |
| K260050 | WRAP System | Huneo, LLC | 2026-07-15 | 189 | 0 |
| K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | 2026-06-22 | 270 | 0 |
| K252628 | CASSIE | Wesper, Inc. | 2026-04-27 | 250 | 0 |
| K252497 | SANSA HSAT | Huxley Medical | 2025-12-10 | 124 | 0 |
| K250882 | SANSA HSAT | Huxley Medical | 2025-10-29 | 219 | 0 |
| K250460 | WatchPAT400 (WP400) | Itamar Medical , Ltd. | 2025-09-05 | 199 | 0 |
| K252383 | Somfit D | Compumedics Limited | 2025-08-28 | 28 | 0 |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | 2025-07-03 | 269 | 0 |
| K242224 | Happy Health Home Sleep Test | Happy Health, Inc. | 2025-06-18 | 324 | 0 |
| K243092 | AcuPebble Ox (200) | Acurable Limited | 2025-03-19 | 170 | 0 |
| K243268 | TipTraQ (TTQ001) | Pranaq Pte. , Ltd. | 2025-02-03 | 111 | 0 |
| K244027 | SANSA HSAT | Huxley Medical | 2025-01-28 | 29 | 0 |
| K242290 | DormoTech NLab | Dormotech Medical, Ltd. | 2025-01-08 | 159 | 0 |
| K242424 | Bluebird Single-Use Respiratory Effort Belt | Cadwell Industries, Inc. | 2024-12-18 | 125 | 0 |
| K231667 | Withings Sleep Rx | Withings | 2024-09-06 | 457 | 0 |
| K233501 | “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examin | Largan Medical Co., Ltd. | 2024-07-26 | 269 | 0 |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | 2024-07-15 | 165 | 0 |
| K240100 | SAM Model 9-10000 | Snap Diagnostics, LLC | 2024-06-04 | 144 | 0 |
| K231355 | Aurora | Ensodata | 2024-02-09 | 275 | 0 |
| K231546 | Somfit | Compumedics Limited | 2023-11-30 | 184 | 0 |
| K223573 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2023-08-18 | 261 | 0 |
| K221816 | Wesper Lab | Wesper, Inc. | 2023-03-09 | 260 | 0 |
| K222579 | Belun Sleep System BLS-100 | Belun Technology Company Limited | 2023-02-23 | 182 | 0 |
| K222950 | AcuPebble OX100 | Acurable Limited | 2023-02-03 | 129 | 0 |
| K223675 | WatchPAT ONE (WP1) | Itamar Medical , Ltd. | 2023-01-06 | 30 | 0 |
| K220012 | BresoDX1 | Bresotec, Inc. | 2022-12-21 | 351 | 0 |
| K222331 | WatchPAT300 (WP300) | Itamar Medical , Ltd. | 2022-09-14 | 43 | 0 |
| K220095 | ANNE Sleep | Sibel, Inc. | 2022-07-11 | 180 | 0 |
| K213360 | SleepCheckRx | Resapp Health | 2022-07-05 | 266 | 0 |
| K210593 | Onera Sleep Test System (Onera STS) | Onera B.V. | 2022-04-06 | 401 | 0 |
| K203839 | WatchPAT200U (WP200U) | Itamar Medical , Ltd. | 2022-03-21 | 446 | 0 |
| K220028 | NightOwl | Ectosense NV | 2022-02-24 | 50 | 0 |
| K203343 | Wesper Lab | Wesper, Inc. | 2021-12-21 | 403 | 0 |
| K213463 | NightOwl | Ectosense NV | 2021-12-16 | 50 | 0 |
| K210480 | AcuPebble SA | Acurable Limited | 2021-07-06 | 137 | 0 |
| K201495 | Maxxi Flow Sensor | Neurovirtual USA, Inc. | 2020-12-14 | 192 | 0 |
| K200695 | MATRx plus | Zephyr Sleep Technologies | 2020-08-24 | 160 | 0 |
| K200654 | Rubicon SA System | Dymedix Diagnostics, Inc. | 2020-07-22 | 132 | 0 |
| K191031 | NightOwl | Ectosense NV | 2020-03-06 | 323 | 0 |
| K191095 | Maxxi Snore Sensor | Neurovirtual USA, Inc. | 2020-01-16 | 266 | 0 |
| K191925 | MATRx Plus | Zephyr Sleep Technologies | 2019-10-29 | 103 | 0 |
| K183625 | SomnaPatch | Respironics, Inc. | 2019-10-18 | 296 | 0 |
| K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small | Embla Systems | 2019-09-27 | 633 | 0 |
| K182618 | SleepImage System | Mycardio, LLC Dba Sleepimage. | 2019-08-14 | 324 | 0 |
| K173974 | DROWZLE | Resonea, Inc. | 2019-07-14 | 562 | 0 |
| K171304 | Maxxi Rip Sensor | Neurovirtual USA, Inc. | 2019-06-24 | 782 | 0 |
| K183559 | WatchPAT ONE | Itamar Medical , Ltd. | 2019-06-05 | 167 | 0 |
| K173793 | XactTrace Single Use Respiratory Effort Belt System | Embla Systems | 2019-03-01 | 442 | 0 |
| K181996 | MATRx Plus | Zephyr Sleep Technologies | 2018-11-21 | 118 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda