Liberty Healthcare Group, Inc.: FDA clearances and approvals
Liberty Healthcare Group, Inc. has 5 FDA 510(k) clearances (first 2005, latest 2007), across 1 product code in 1 review panel. Median 510(k) review time: 35 days.
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 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 5 | 5 |
Review panels
Most recent Liberty Healthcare Group, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063855 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLUCOSE CONTROL SOLUTION, MODEL 2120047 | JJX | 2007-02-01 | 35 |
| K060706 | LIBERTY NORMAL GLUCOSE CONTROL SOLUTION | JJX | 2006-04-28 | 43 |
| K060481 | LIBERTY GLUCOSE CONTROL SOLUTION | JJX | 2006-03-09 | 14 |
| K060426 | LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 | JJX | 2006-03-09 | 16 |
| K052980 | LIBERTY GLUCOSE CONTROL, MODEL 2120031 | JJX | 2005-11-30 | 37 |
Recalls
openFDA lists no recalls under a recalling firm named Liberty Healthcare Group, 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 Liberty Healthcare Group, Inc. have?
Liberty Healthcare Group, Inc. has 5 FDA 510(k) clearances (first 2005, latest 2007), across 1 product code in 1 review panel.
How long does FDA take to clear Liberty Healthcare Group, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Liberty Healthcare Group, Inc.'s cleared 510(k)s is 35 days.
What devices does Liberty Healthcare Group, Inc. make?
Its most frequent FDA product codes are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 5).
Has Liberty Healthcare Group, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Liberty Healthcare Group, Inc. Related entities may recall under other names.
Next steps
- See all 5 Liberty Healthcare Group, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Liberty Healthcare Group, 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.