Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.” (first 2012, latest 2022), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 138 days. Since 2017 the median was 142 days, against 119 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 51 |
| 2013 | 0 | — |
| 2014 | 2 | 206 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 3 | 138 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 198 |
| 2022 | 2 | 142 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 4 | 4 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
- Radiology (5)
- Cardiovascular (4)
Most recent Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221267 | VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor | MWI | 2022-12-15 | 227 |
| K222754 | ViewMate Multi Ultrasound System | IYN | 2022-11-09 | 58 |
| K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System | IYN | 2021-04-08 | 198 |
| K173369 | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | IYN | 2017-12-13 | 47 |
| K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | IYN | 2017-09-12 | 138 |
| K170712 | Accutorr 7/VS-900 Vital Signs Monitor | MWI | 2017-08-02 | 146 |
| K143195 | Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) | MHX | 2014-12-22 | 46 |
| K132036 | HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) | MSX | 2014-07-01 | 365 |
| K113632 | DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | IYO | 2012-01-25 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (159 510(k)s)
- Shenzhen Dongdixin Technology Co., Ltd. (26 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (13 510(k)s)
- Shenzhen Osto Technology Company Limited (12 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.” (first 2012, latest 2022), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. is 138 days. Since 2017: 142 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 2); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 9 Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYN, Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.