Focal Therapeutics: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Focal Therapeutics” (first 2012, latest 2019), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 120 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 | 120 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 116 |
| 2016 | 0 | — |
| 2017 | 1 | 175 |
| 2018 | 0 | — |
| 2019 | 1 | 27 |
| 2020 | 0 | — |
| 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 Focal Therapeutics took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | 4 | 4 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
Review panels
Most recent Focal Therapeutics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192371 | BioZorb SP Marker | NEU | 2019-09-26 | 27 |
| K171467 | BioZorb Marker GOLD / LP Marker GOLD | IYE | 2017-11-09 | 175 |
| K152070 | BioZorb LP Marker | NEU | 2015-08-26 | 30 |
| K143484 | BioZorb Marker | NEU | 2015-06-29 | 203 |
| K113202 | TISSUE MARKER | NEU | 2012-02-28 | 120 |
Recalls
openFDA lists no recalls under a recalling firm named Focal Therapeutics.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Focal Therapeutics (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Focal Change (1 510(k)s)
- Focal Healtcare, Inc. (1 510(k)s)
- Focal Healthcare, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Focal Therapeutics?
FDA lists 5 510(k) clearances under the applicant name “Focal Therapeutics” (first 2012, latest 2019), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Focal Therapeutics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Focal Therapeutics is 120 days.
Which FDA product codes appear under Focal Therapeutics?
The most frequent FDA product codes under this applicant name are NEU (Marker, Radiographic, Implantable, 4); IYE (Accelerator, Linear, Medical, 1).
Next steps
- See all 5 Focal Therapeutics clearances with predicates and recalls
- Run predicate analysis for product code NEU, Focal Therapeutics'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.