Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Belter Health Measurement and Analysis TE · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140681 | BELTER INFRA-RED EAR THERMOMETER | Shenzhen Belter Health Measurement and Analysis TE | 2014-08-21 | 156 | 0 |
| K134029 | BELTER BLOOD PRESSURE METER | Shenzhen Belter Health Measurement and Analysis TE | 2014-07-25 | 206 | 0 |
| K122976 | BODY FAT SCALE MODEL SF-371 | Shenzhen Belter Health Measurement and Analysis TE | 2013-01-04 | 100 | 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