Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MHX — Predicate Candidate Screening
427 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
273 days90th percentile
427clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251508 | Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. | 2026-08-06 | 447 | 0 |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; | Ge Medical Systems Information Technologies, Inc. | 2026-07-24 | 298 | 0 |
| K254209 | Radius VSM and Accessories | Masimo Corporation | 2026-06-04 | 157 | 0 |
| K252840 | M12 Telemetry System | Global Instrumentation, LLC | 2026-05-29 | 266 | 0 |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-20 | 127 | 0 |
| K250349 | Vista CMS | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-24 | 441 | 0 |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-16 | 202 | 0 |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (260106 | Shanghai Draeger Medical Instrument Co., Ltd. | 2026-04-10 | 267 | 0 |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue | Philips Medizin Systeme Boeblingen GmbH | 2026-02-06 | 162 | 0 |
| K252589 | Corvair Monza | AliveCor, Inc. | 2026-01-09 | 147 | 0 |
| K250854 | Multi-parameter Patient Monitor (N10); Multi-parameter Patie | Shenzhen Comen Medical Instruments Co.,Ltd | 2025-12-17 | 271 | 0 |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor | Philips Medizin Systeme Böblingen GmbH | 2025-11-10 | 161 | 0 |
| K251146 | IntelliVue Patient monitors MX400, MX450, MX500, MX550 | Philips Medizin Systeme Boeblingen GmbH | 2025-10-17 | 186 | 0 |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient M | Philips Medizin Systeme Böblingen GmbH | 2025-09-02 | 196 | 0 |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) | Edan Instruments, Inc. | 2025-07-29 | 188 | 0 |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; | Ge Medical Systems Information Technologies, Inc. | 2025-07-09 | 315 | 0 |
| K250757 | Radius VSM and Accessories | Masimo Corporation | 2025-05-29 | 78 | 0 |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232) | Philips Medizin Systeme Böblingen GmbH | 2025-05-05 | 222 | 1 |
| K240312 | Infinity CentralStation Wide | Draeger Medical Systems, Inc. | 2024-08-01 | 181 | 0 |
| K240320 | Patient Monitor (RespArray) | Edan Instruments, Inc. | 2024-06-28 | 147 | 0 |
| K231010 | Corvair | AliveCor, Inc. | 2024-06-07 | 427 | 0 |
| K232962 | Patient Monitor (iX10, iX12, iX15) | Edan Instruments, Inc. | 2024-04-19 | 211 | 1 |
| K232694 | Central Monitoring System (MFM-CMS) | Edan Instruments, Inc. | 2024-02-05 | 153 | 1 |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patien | Philips Medizin Systeme Boeblingen GmbH | 2023-12-19 | 194 | 0 |
| K230604 | IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi- | Philips Medizin Systeme Boeblingen GmbH | 2023-11-22 | 264 | 0 |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+ | Draeger Medical Systems, Inc. | 2023-10-17 | 148 | 0 |
| K223574 | IntelliVue Patient Monitor MX400 (866060), IntelliVue Patien | Philips Medizin Systeme Boeblingen GmbH | 2023-08-22 | 265 | 0 |
| K221056 | ARGUS PB-3000 | Schiller AG | 2023-07-06 | 451 | 1 |
| K223498 | Radius VSM and Accessories | Masimo Corporation | 2023-06-01 | 192 | 2 |
| K223531 | CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARES | GE Healthcare Finland Oy | 2023-04-06 | 134 | 3 |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient | Philips Medizin Systeme Böblingen GmbH | 2023-02-03 | 270 | 0 |
| K211619 | Multi-Parameter Patient Monitor | Shenzhen Comen Medical Instruments Co.,Ltd | 2022-12-29 | 582 | 0 |
| K222586 | Mural Clinical Viewer | Ge Medical Systems Information Technologies, Inc. | 2022-12-21 | 117 | 0 |
| K221904 | EK12 V2 Algorithm | Ge Medical Systems Information Technologies, Inc. | 2022-12-20 | 173 | 0 |
| K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | 2022-08-11 | 190 | 0 |
| K221879 | Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 | Caf Medical Solutions, Inc. | 2022-08-10 | 43 | 0 |
| K221616 | Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 | Caf Medical Solutions, Inc. | 2022-08-01 | 59 | 0 |
| K220989 | Next Generation NetKonnect | Nihon Kohden Digital Health Solutions, Inc. | 2022-07-29 | 116 | 0 |
| K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-07-12 | 218 | 1 |
| K213363 | CARESCAPE B450, E-musb | GE Healthcare Finland Oy | 2022-04-13 | 183 | 1 |
| K213336 | Carescape B850, E-musb | GE Healthcare Finland Oy | 2022-04-13 | 189 | 1 |
| K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | 2022-04-13 | 196 | 2 |
| K213234 | CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 an | Ge Medical Systems Information Technologies, Inc. | 2022-04-12 | 194 | 1 |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, | Ge Medical Systems Information Technologies, Inc. | 2022-04-01 | 151 | 6 |
| K211900 | Patient Information Center iX | Philips Medizin Systeme Böblingen GmbH | 2022-03-04 | 256 | 0 |
| K203088 | Infinity Acute Care System (IACS) Monitoring System | Draeger Medical Systems, Inc. | 2022-02-01 | 476 | 1 |
| K201764 | Infinity Acute Care System (IACS) Monitoring Solution | Draeger Medical Systems, Inc. | 2021-12-09 | 528 | 0 |
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2021-10-07 | 195 | 2 |
| K203435 | Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon | Nihon Kohden Corporation | 2021-07-16 | 235 | 0 |
| K202336 | Patient Monitor | Edan Instruments, Inc. | 2021-01-23 | 159 | 1 |
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