Mindray: FDA 510(k) clearances across all its applicant names

FDA lists 168 510(k) clearances, 0 PMA and 0 De Novo decisions across the 4 applicant names Caduvo groups under Mindray, first 2004, latest 2026. Median 510(k) review time across these names: 110 days. Since 2017 the median was 127 days, against 137 days for all cleared 510(k)s in the same product codes. Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

510(k) clearances per year

The 4 FDA applicant names in this group

Review time against the same product codes

Since 2017, 510(k)s cleared under these names 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 (43)
• Anesthesiology (17)
• Clinical Chemistry (4)
• Hematology (4)

Most recent Mindray 510(k) clearances

158 earlier clearances. See the full list in Caduvo.

How this group is built

Groups are curated by Caduvo from public sources listed below; FDA does not group applicants. Counts include filings made before an acquisition, and can include older filings by a business that was later sold when FDA records them under the same applicant name; see the notes on this page.

Mindray entity names. Left out: Datascope — Mindray bought only Datascope's patient-monitoring business (2008); the rest went to Getinge.

Sources

• https://en.wikipedia.org/wiki/Mindray

Frequently asked questions

How many FDA 510(k) clearances are listed across Mindray's applicant names?

FDA lists 168 510(k) clearances, 0 PMA and 0 De Novo decisions across the 4 applicant names Caduvo groups under Mindray, first 2004, latest 2026. FDA records each applicant name separately; Caduvo adds up the names listed on this page.

Which FDA applicant names does Mindray file under?

The names with the most 510(k) clearances in this group are Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (160); Mindray DS USA, Inc. (3); Mindray North America (3); Mindray Bio-Medical Electronics Co., Ltd. (2). The full list of 4 names is on this page.

How long does FDA take to clear Mindray 510(k)s?

The median time from FDA receipt to decision across 510(k)s cleared under these names is 110 days. Since 2017 the median was 127 days, against 137 days for all cleared 510(k)s in the same product codes.

Does the Mindray count include acquired companies?

Yes. A group includes filings an acquired business made under its own name, including before the acquisition. Businesses that were sold are left out, and names whose ownership is unclear are not included. FDA does not group applicants; the sources for each grouping are listed on this page.

Next steps

• See all 168 Mindray clearances with predicates and recalls
• Run predicate analysis for product code IYN, Mindray's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls). Applicant names are matched exactly, with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this grouping or data.

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