Infopia Co, Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Infopia Co, Ltd.” (first 2005, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 196 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 147 |
| 2013 | 4 | 113 |
| 2014 | 3 | 195 |
| 2015 | 1 | 203 |
| 2016 | 1 | 232 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 15 | 15 |
| LCP | Assay, Glycosylated Hemoglobin | 3 | 3 |
| CGA | Glucose Oxidase, Glucose | 2 | 2 |
Review panels
- Clinical Chemistry (17)
- Hematology (3)
Most recent Infopia Co, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System | NBW | 2016-09-28 | 232 |
| K150274 | GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System | NBW | 2015-08-26 | 203 |
| K141750 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | LCP | 2014-07-24 | 24 |
| K132406 | ELEMENTV BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2014-04-18 | 259 |
| K133045 | ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2014-04-10 | 195 |
| K132862 | HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-12-12 | 91 |
| K132966 | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-12-05 | 76 |
| K130181 | GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-07-31 | 187 |
| K130295 | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. | NBW | 2013-06-21 | 135 |
| K121366 | HEMOCUE HBA1C 501 | LCP | 2012-09-07 | 123 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Infopia Co, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Infopia Co, Ltd.?
FDA lists 20 510(k) clearances under the applicant name “Infopia Co, Ltd.” (first 2005, latest 2016), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Infopia Co, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Infopia Co, Ltd. is 196 days.
Which FDA product codes appear under Infopia Co, Ltd.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 15); LCP (Assay, Glycosylated Hemoglobin, 3); CGA (Glucose Oxidase, Glucose, 2).
Next steps
- See all 20 Infopia Co, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Infopia Co, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.