Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sd Biosensor · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System | Sd Biosensor | 2017-10-17 | 623 | 0 |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD | Sd Biosensor | 2016-06-24 | 233 | 0 |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Mul | Sd Biosensor | 2015-11-24 | 195 | 0 |
| K123517 | GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MUL | Sd Biosensor | 2014-01-17 | 429 | 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