Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioland Technology, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
197 daysmedian FDA review time
693 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G- | Bioland Technology, Ltd. | 2022-08-12 | 693 | 0 |
| K213011 | Infrared Thermometer (model: E201) | Bioland Technology, Ltd. | 2022-04-05 | 197 | 0 |
| K201879 | Digital Thermometer Model T103, T104 | Bioland Technology, Ltd. | 2021-03-31 | 267 | 0 |
| K202934 | Blood Pressure Monitor | Bioland Technology, Ltd. | 2021-01-26 | 119 | 0 |
| K201161 | Infrared Thermometer Model E127 | Bioland Technology, Ltd. | 2020-10-02 | 155 | 0 |
| K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | Bioland Technology, Ltd. | 2020-09-21 | 111 | 0 |
| K191657 | Bioland Blood Glucose Monitoring System | Bioland Technology, Ltd. | 2020-03-20 | 273 | 0 |
| K083681 | BIOLAND BLOOD PRESSURE MONITOR | Bioland Technology, Ltd. | 2009-01-16 | 35 | 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