Guangzhou Berrcom Medical Device Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Guangzhou Berrcom Medical Device Co., Ltd.” (first 2019, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 150 days. Since 2017 the median was 150 days, against 209 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 |
|---|---|---|
| 2019 | 1 | 153 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 4 | 138 |
| 2023 | 1 | 389 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Guangzhou Berrcom Medical Device Co., Ltd. took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 209 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Guangzhou Berrcom Medical Device Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K214077 | Digital Thermometer, Model: DT007, DT008 | FLL | 2023-01-20 | 389 |
| K213746 | Digital thermometer, Model DT101, DT102 | FLL | 2022-04-05 | 127 |
| K213084 | Ear Thermometer, Model ET005, ET008, ET009 | FLL | 2022-02-25 | 155 |
| K213079 | Ear Thermometer, Model ET001 | FLL | 2022-02-18 | 148 |
| K213082 | Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 | FLL | 2022-01-28 | 127 |
| K191570 | Infrared Thermometer Model MD-H30 | FLL | 2019-11-13 | 153 |
Recalls
openFDA lists no recalls under a recalling firm named Guangzhou Berrcom Medical Device 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.
- Guangzhou Wondfo Biotech Co., Ltd. (43 510(k)s)
- Guangzhou Xinbo Electronic Co., Ltd. (12 510(k)s)
- Guangzhou Red Pine Medical Instrument Co., Ltd. (10 510(k)s)
- Guangzhou Decheng Biotechnology Co., Ltd. (8 510(k)s)
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (7 510(k)s)
- Guangzhou Longest Science & Technology Co., Ltd. (6 510(k)s)
- Guangzhou Heygears IMC., Inc. (4 510(k)s)
- Guangzhou Ajax Medical Equipment Co., Ltd. (3 510(k)s)
- Guangzhou Finecure Medical Equipment Co.,Ltd (3 510(k)s)
- Guangzhou Longest Medical Technology Co., Ltd. (3 510(k)s)
- Guangzhou Sonostar Technologies Co., Ltd. (3 510(k)s)
- Guangzhou Chemicals Import & Export Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Guangzhou Berrcom Medical Device Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Guangzhou Berrcom Medical Device Co., Ltd.” (first 2019, latest 2023), 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 Guangzhou Berrcom Medical Device Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Guangzhou Berrcom Medical Device Co., Ltd. is 150 days. Since 2017: 150 days, versus 209 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Guangzhou Berrcom Medical Device Co., Ltd.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 6).
Next steps
- See all 6 Guangzhou Berrcom Medical Device Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Guangzhou Berrcom Medical Device 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.