Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guangzhou Berrcom Medical Device Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
389 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K214077 | Digital Thermometer, Model: DT007, DT008 | Guangzhou Berrcom Medical Device Co., Ltd. | 2023-01-20 | 389 | 0 |
| K213746 | Digital thermometer, Model DT101, DT102 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-04-05 | 127 | 0 |
| K213084 | Ear Thermometer, Model ET005, ET008, ET009 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-02-25 | 155 | 0 |
| K213079 | Ear Thermometer, Model ET001 | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-02-18 | 148 | 0 |
| K213082 | Non-contact Infrared Thermometer, Models JXB-315, JXB-319, J | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-01-28 | 127 | 0 |
| K191570 | Infrared Thermometer Model MD-H30 | Guangzhou Berrcom Medical Device Co., Ltd. | 2019-11-13 | 153 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda