Shenzhen Biocare Bio-Medical Equipment Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Shenzhen Biocare Bio-Medical Equipment Co., Ltd.” (first 2014, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 148 days. 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 |
|---|---|---|
| 2014 | 1 | 148 |
| 2015 | 3 | 211 |
| 2016 | 1 | 28 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Shenzhen Biocare Bio-Medical Equipment Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160092 | Digital Electrocardiograph | DPS | 2016-02-12 | 28 |
| K152384 | Digital Electrocardiograph | DPS | 2015-12-18 | 116 |
| K141946 | DIGITAL ELECTROCARDIOGRAPH | DPS | 2015-02-13 | 211 |
| K133985 | DIGITAL ELECTROCARDIOGRAPH | DPS | 2015-01-22 | 392 |
| K132758 | DIGITAL ELECTROCARDIOGRAPH | DPS | 2014-01-30 | 148 |
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Biocare Bio-Medical Equipment 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. (160 510(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 RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Root Innovation Technology 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 Biocare Bio-Medical Equipment Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Shenzhen Biocare Bio-Medical Equipment Co., Ltd.” (first 2014, latest 2016), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Biocare Bio-Medical Equipment Co., Ltd. is 148 days.
Which FDA product codes appear under Shenzhen Biocare Bio-Medical Equipment Co., Ltd.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 5).
Next steps
- See all 5 Shenzhen Biocare Bio-Medical Equipment Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Shenzhen Biocare Bio-Medical Equipment 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.