Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Predicate Candidate Screening
159 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
218 days90th percentile
159clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-06-25 | 268 | 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 |
| K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound Sys | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-05-11 | 56 | 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 |
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 | 269 | 0 |
| K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Reson | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-02-11 | 142 | 0 |
| K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-12-03 | 190 | 0 |
| K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-11-07 | 143 | 0 |
| K251820 | ViewMateTM Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-12 | 91 | 0 |
| K251250 | ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Mu | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-09-05 | 135 | 0 |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 | 265 | 0 |
| K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound Sy | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-22 | 127 | 0 |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 | 324 | 0 |
| K250024 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-30 | 144 | 0 |
| K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultraso | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-19 | 136 | 0 |
| K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound Sy | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-05-16 | 120 | 0 |
| K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Reson | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-11-08 | 101 | 0 |
| K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-10-31 | 267 | 0 |
| K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TE | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-16 | 139 | 0 |
| K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-09-12 | 114 | 0 |
| K240906 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-07-23 | 112 | 0 |
| K240684 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-06-17 | 97 | 0 |
| K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-04-22 | 97 | 0 |
| K231685 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-10-26 | 139 | 0 |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-16 | 520 | 0 |
| K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-09 | 81 | 0 |
| K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-02-07 | 134 | 0 |
| K221113 | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-12-02 | 231 | 0 |
| K221300 | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 | 147 | 0 |
| K221496 | Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Co | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-09-29 | 129 | 0 |
| K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-07-12 | 218 | 1 |
| K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 | 146 | 1 |
| K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-03-25 | 56 | 0 |
| K220051 | TE Air Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-03-04 | 57 | 0 |
| K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnost | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-16 | 119 | 0 |
| K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-11-05 | 53 | 0 |
| K211475 | Vital Signs Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-10-05 | 146 | 0 |
| K211337 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnost | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-07-01 | 59 | 0 |
| K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 | 93 | 0 |
| K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-06-10 | 119 | 0 |
| K201957 | A8, A9 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 | 255 | 6 |
| K203391 | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-23 | 125 | 0 |
| K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-01-07 | 139 | 0 |
| K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diag | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-11-09 | 115 | 0 |
| K201693 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AE | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-08-21 | 60 | 0 |
| K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-07-24 | 135 | 0 |
| K200015 | ePM Series Patient monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-06-08 | 157 | 0 |
| K200979 | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-28 | 45 | 0 |
| K193391 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-21 | 167 | 0 |
| K192972 | Patient Monitor | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2020-05-07 | 196 | 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