Epocal, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Epocal, Inc.” (first 2006, latest 2020), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 195 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 | 1 | 291 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 264 |
| 2019 | 0 | — |
| 2020 | 1 | 140 |
| 2021 | 0 | — |
| 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 Epocal, Inc. took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 234 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDS | Electrode, Ion Specific, Urea Nitrogen | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 1 | 1 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 | 1 |
Review panels
Most recent Epocal, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200107 | epoc Blood Analysis System | CHL | 2020-06-05 | 140 |
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test | CDS | 2018-01-17 | 264 |
| K113726 | EPOC CHLORIDE TEST AND EPOC CREATININE TEST | CGL | 2012-10-05 | 291 |
| K093297 | EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE | KHP | 2010-06-09 | 231 |
| K092849 | BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER | CEM | 2010-03-30 | 195 |
| K090109 | BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD | CGA | 2009-06-24 | 160 |
| K061597 | EPOC BLOOD ANALYSIS SYSTEM | JGS | 2006-09-27 | 111 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2013-03-13.
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 Epocal, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Epocal, Inc.” (first 2006, latest 2020), across 7 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 Epocal, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Epocal, Inc. is 195 days.
Which FDA product codes appear under Epocal, Inc.?
The most frequent FDA product codes under this applicant name are CDS (Electrode, Ion Specific, Urea Nitrogen, 1); CEM (Electrode, Ion Specific, Potassium, 1); CGA (Glucose Oxidase, Glucose, 1).
Next steps
- See all 7 Epocal, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDS, Epocal, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.