Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: FDA filings under this applicant name

FDA lists 159 510(k) clearances under the applicant name “Shenzhen Mindray Bio-Medical Electronics Co., Ltd.” (first 2004, latest 2026), across 17 product codes in 5 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 127 days, against 137 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.

Caduvo groups this applicant name under Mindray, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Shenzhen Mindray Bio-Medical Electronics Co., Ltd. took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.

Top product codes

Plus 7 more product codes.

Review panels

• Radiology (100)
• Cardiovascular (37)
• Anesthesiology (16)
• Clinical Chemistry (4)
• Hematology (2)

Most recent Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 510(k) clearances

149 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Shenzhen Mindray Bio-Medical 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 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)
• Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Shenzhen Mindray Bio-Medical Electronics Co., Ltd.?

FDA lists 159 510(k) clearances under the applicant name “Shenzhen Mindray Bio-Medical Electronics Co., Ltd.” (first 2004, latest 2026), across 17 product codes in 5 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-Medical Electronics Co., Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is 104 days. Since 2017: 127 days, versus 137 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Shenzhen Mindray Bio-Medical Electronics Co., Ltd.?

The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 83); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 22); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 11).

Next steps

• See all 159 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. clearances with predicates and recalls
• Run predicate analysis for product code IYN, Shenzhen Mindray Bio-Medical 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.

All FDA device companies · FDA product code lookup