Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
138 daysmedian FDA review time
365 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221267 | VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vi | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-12-15 | 227 | 0 |
| K222754 | ViewMate Multi Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2022-11-09 | 58 | 0 |
| K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,N | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2021-04-08 | 198 | 0 |
| K173369 | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-12-13 | 47 | 0 |
| K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnos | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-09-12 | 138 | 0 |
| K170712 | Accutorr 7/VS-900 Vital Signs Monitor | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-08-02 | 146 | 0 |
| K143195 | Passport Series Patient Monitors (including Passport 17M, Pa | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014-12-22 | 46 | 0 |
| K132036 | HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MO | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2014-07-01 | 365 | 0 |
| K113632 | DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGIT | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2012-01-25 | 51 | 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