Foracare, Inc.: FDA clearances and approvals
Foracare, Inc. has 5 FDA 510(k) clearances (first 2011, latest 2018), across 4 product codes in 3 review panels. Median 510(k) review time: 182 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 64 |
| 2013 | 1 | 220 |
| 2014 | 1 | 155 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 269 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Foracare, Inc.'s cleared 510(k)s took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
Review panels
- Clinical Chemistry (2)
- Cardiovascular (2)
- General Hospital (1)
Most recent Foracare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173505 | FORA GTel Blood Glucose Monitoring System | NBW | 2018-08-09 | 269 |
| K133588 | FORA CARE BLOOD PRESSURE MONITORING SYSTEM | DXN | 2014-04-25 | 155 |
| K121706 | FORA V10 BLOOD GLUCOSE MONITORING SYSTEM | CGA | 2013-01-14 | 220 |
| K121118 | FORA COMFORTSCAN EAR THERMOMETER | FLL | 2012-06-15 | 64 |
| K110044 | FORA P30 PLUS MULTI-MODE BLOOD PRESSURE MONITORING SYSTEM | DXN | 2011-07-07 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Foracare, Inc..
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 Foracare, Inc. have?
Foracare, Inc. has 5 FDA 510(k) clearances (first 2011, latest 2018), across 4 product codes in 3 review panels.
How long does FDA take to clear Foracare, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Foracare, Inc.'s cleared 510(k)s is 182 days.
What devices does Foracare, Inc. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); CGA (Glucose Oxidase, Glucose, 1); FLL (Continuous Measurement Thermometer, 1).
Has Foracare, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Foracare, Inc. Related entities may recall under other names.
Next steps
- See all 5 Foracare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Foracare, Inc.'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.