Foley & Lardner: FDA clearances and approvals
Foley & Lardner has 5 FDA 510(k) clearances (first 1994, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time: 178 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | 4 | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
Review panels
- Physical Medicine (4)
- Cardiovascular (1)
Most recent Foley & Lardner 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973613 | CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER | DXN | 1998-04-14 | 204 |
| K942311 | DYNASTY U1-33 AGM | KNN | 1994-11-07 | 178 |
| K942310 | DYNASTY GC 12550 (GELL/CELL) | KNN | 1994-11-07 | 178 |
| K942309 | DYNASTY U1-31 (GELL/CELL) | KNN | 1994-11-07 | 178 |
| K942308 | DYNASTY GC 12400 (GELL/CELL) | KNN | 1994-11-07 | 178 |
Recalls
openFDA lists no recalls under a recalling firm named Foley & Lardner.
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 Foley & Lardner have?
Foley & Lardner has 5 FDA 510(k) clearances (first 1994, latest 1998), across 2 product codes in 2 review panels.
How long does FDA take to clear Foley & Lardner's 510(k)s?
The median time from FDA receipt to decision across Foley & Lardner's cleared 510(k)s is 178 days.
What devices does Foley & Lardner make?
Its most frequent FDA product codes are KNN (Components, Wheelchair, 4); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Has Foley & Lardner had device recalls?
openFDA lists no recalls under a recalling firm name matching Foley & Lardner. Related entities may recall under other names.
Next steps
- See all 5 Foley & Lardner clearances with predicates and recalls
- Run predicate analysis for product code KNN, Foley & Lardner'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.