Bioland Technology, Ltd.: FDA clearances and approvals
Bioland Technology, Ltd. has 8 FDA 510(k) clearances (first 2009, latest 2022), across 3 product codes in 3 review panels. Median 510(k) review time: 176 days. Since 2017 its median was 197 days, against 185 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 3 | 155 |
| 2021 | 2 | 193 |
| 2022 | 2 | 445 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bioland Technology, Ltd.'s cleared 510(k)s took a median 197 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 185 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| NBW | System, Test, Blood Glucose, Over The Counter | 2 | 2 |
Review panels
- Cardiovascular (3)
- General Hospital (3)
- Clinical Chemistry (2)
Most recent Bioland Technology, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | NBW | 2022-08-12 | 693 |
| K213011 | Infrared Thermometer (model: E201) | FLL | 2022-04-05 | 197 |
| K201879 | Digital Thermometer Model T103, T104 | FLL | 2021-03-31 | 267 |
| K202934 | Blood Pressure Monitor | DXN | 2021-01-26 | 119 |
| K201161 | Infrared Thermometer Model E127 | FLL | 2020-10-02 | 155 |
| K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B | DXN | 2020-09-21 | 111 |
| K191657 | Bioland Blood Glucose Monitoring System | NBW | 2020-03-20 | 273 |
| K083681 | BIOLAND BLOOD PRESSURE MONITOR | DXN | 2009-01-16 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Bioland Technology, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bioland Technology, Ltd. have?
Bioland Technology, Ltd. has 8 FDA 510(k) clearances (first 2009, latest 2022), across 3 product codes in 3 review panels.
How long does FDA take to clear Bioland Technology, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bioland Technology, Ltd.'s cleared 510(k)s is 176 days. Since 2017: 197 days, versus 185 days for all cleared 510(k)s in the same product codes.
What devices does Bioland Technology, Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); FLL (Continuous Measurement Thermometer, 3); NBW (System, Test, Blood Glucose, Over The Counter, 2).
Has Bioland Technology, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bioland Technology, Ltd. Related entities may recall under other names.
Next steps
- See all 8 Bioland Technology, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Bioland Technology, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.