Eps Bio Technology Corp.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Eps Bio Technology Corp.” (first 2005, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 273 days, against 228 days for all cleared 510(k)s in the same product codes. 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 | 2 | 88 |
| 2013 | 0 | — |
| 2014 | 3 | 161 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 24 |
| 2019 | 1 | 273 |
| 2020 | 0 | — |
| 2021 | 1 | 478 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eps Bio Technology Corp. took a median 273 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 228 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 14 | 14 |
| LFR | Glucose Dehydrogenase, Glucose | 6 | 6 |
| CGA | Glucose Oxidase, Glucose | 4 | 4 |
Review panels
- Clinical Chemistry (24)
Most recent Eps Bio Technology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose System | NBW | 2021-09-01 | 478 |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose System | NBW | 2019-11-01 | 273 |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose System | NBW | 2018-08-24 | 24 |
| K133537 | EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM | LFR | 2014-04-28 | 161 |
| K133389 | EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM | NBW | 2014-04-15 | 161 |
| K133647 | EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM | NBW | 2014-02-27 | 92 |
| K121207 | EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | 2012-05-18 | 28 |
| K113243 | EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | 2012-03-28 | 147 |
| K112901 | EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | LFR | 2011-12-23 | 81 |
| K111728 | EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM | CGA | 2011-09-16 | 88 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eps Bio Technology Corp..
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 Eps Bio Technology Corp.?
FDA lists 24 510(k) clearances under the applicant name “Eps Bio Technology Corp.” (first 2005, latest 2021), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Eps Bio Technology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eps Bio Technology Corp. is 94 days. Since 2017: 273 days, versus 228 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eps Bio Technology Corp.?
The most frequent FDA product codes under this applicant name are NBW (System, Test, Blood Glucose, Over The Counter, 14); LFR (Glucose Dehydrogenase, Glucose, 6); CGA (Glucose Oxidase, Glucose, 4).
Next steps
- See all 24 Eps Bio Technology Corp. clearances with predicates and recalls
- Run predicate analysis for product code NBW, Eps Bio Technology Corp.'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.