Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Focal Therapeutics — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
203 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192371 | BioZorb SP Marker | Focal Therapeutics | 2019-09-26 | 27 | 0 |
| K171467 | BioZorb Marker GOLD / LP Marker GOLD | Focal Therapeutics | 2017-11-09 | 175 | 0 |
| K152070 | BioZorb LP Marker | Focal Therapeutics | 2015-08-26 | 30 | 3 |
| K143484 | BioZorb Marker | Focal Therapeutics | 2015-06-29 | 203 | 1 |
| K113202 | TISSUE MARKER | Focal Therapeutics | 2012-02-28 | 120 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda