Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MSX — Predicate Candidate Screening
118 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
266 days90th percentile
118clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261367 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2026-07-26 | 90 | 0 |
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 | 130 | 0 |
| K243270 | TigerConnect Alarm Management | Tigerconnect | 2025-09-30 | 349 | 0 |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 | 324 | 0 |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 | 266 | 0 |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025-01-08 | 111 | 0 |
| K241397 | Hinscope | Hinlab Sas | 2024-11-14 | 182 | 0 |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024-07-12 | 221 | 0 |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 | 212 | 0 |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-03-22 | 212 | 0 |
| K231506 | Current Health System | Current Health , Ltd. | 2023-08-24 | 92 | 0 |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023-07-31 | 244 | 0 |
| K213863 | Everion+ System | Biofourmis Singapore Pte., Ltd. | 2023-02-23 | 440 | 0 |
| K222550 | Current Health System | Current Health , Ltd. | 2022-11-01 | 70 | 0 |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022-06-07 | 547 | 0 |
| K211046 | eCareManager 4.5 | Visicu, Inc. | 2022-06-03 | 421 | 0 |
| K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 | 146 | 1 |
| K212622 | Zyter RPM | Zyter, Inc. | 2022-02-11 | 177 | 0 |
| K211949 | AirStrip ONE Web Client with Alarm Communication Management | Airstrip Technologies, Inc. | 2021-12-09 | 169 | 0 |
| K210160 | AlertWatch:AC | Alertwatch, Inc. | 2021-09-10 | 232 | 0 |
| K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021-09-03 | 227 | 0 |
| K202497 | Aulisa Multiple Patient Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2020-10-30 | 60 | 0 |
| K193421 | Smart Alarm Interface | Boxview, LLC | 2020-10-30 | 326 | 0 |
| K192952 | Spire Health Remote Patient Monitoring System | Spire, Inc. D/B/A Spire Health | 2020-06-05 | 228 | 0 |
| K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-21 | 167 | 0 |
| K193043 | Critical Alert CommonPath Enterprise | Critical Alert | 2020-05-11 | 193 | 0 |
| K191272 | Wearable Device, Wearable Package | Current Health , Ltd. | 2019-07-12 | 60 | 0 |
| K182637 | Philips IntelliVue XDS Software | Philips Medizin Systeme Boeblingen GmbH | 2019-04-26 | 214 | 0 |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Ho | Current Health , Ltd. | 2019-03-27 | 70 | 0 |
| K183238 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-03-13 | 113 | 0 |
| K180430 | Digistat Smart Central | Ascom Ums Srl Unipersonale | 2018-11-23 | 280 | 0 |
| K182543 | Wearable Device ; Cradle ; Small Strap, Medium Strap, Large | Snap40, Ltd. | 2018-11-14 | 58 | 0 |
| K180566 | Unite Connect for Clinical Systems | Ascom Sweden AB | 2018-04-03 | 29 | 0 |
| K173203 | Athena GTX Device Management Suite (ADMS) Software | Athena Gtx | 2018-03-14 | 163 | 0 |
| K171322 | eCareManager 4.1 | Visicu, Inc. | 2017-08-03 | 90 | 0 |
| K162607 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-04-20 | 213 | 0 |
| K153156 | eCareManager 4.0.1 | Visicu, Inc. | 2016-09-30 | 333 | 0 |
| K160862 | AirStrip RPM | Airstrip Technologies, Inc. | 2016-09-19 | 174 | 0 |
| K161164 | CareEvent inclusive of the CareEvent Mobile Application acce | Philips Medical Systems | 2016-06-24 | 60 | 3 |
| K151672 | Cerner CareAware Event Management | Cerner Corporation | 2015-12-21 | 182 | 0 |
| K151006 | EarlySense Central Display Station (CDS) | Earlysense, Ltd. | 2015-08-31 | 138 | 0 |
| K150632 | Hypervisor IX Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-07-06 | 117 | 0 |
| K140852 | VECTRAPLEX CMS | Vectracor, Inc. | 2015-01-30 | 302 | 0 |
| K142935 | CareEvent | Philips Medical Systems | 2015-01-15 | 98 | 0 |
| K141756 | INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WOR | Draeger Medical Systems, Inc. | 2014-12-12 | 165 | 0 |
| K143057 | M3290B Philips IntelliVue Information Center iX | Philips Medical Systems | 2014-12-03 | 40 | 0 |
| K132036 | HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MO | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014-07-01 | 365 | 0 |
| K130707 | ISIRONA MAGELLAN | Isirona, LLC | 2013-11-20 | 250 | 0 |
| K130339 | CLINICAL ALERT NOTIFICATION | Extension , Inc. | 2013-07-11 | 150 | 0 |
| K121865 | ZOLL RESCUENET 12-LEAD | ZOLL Medical Corporation | 2012-11-20 | 147 | 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