Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pentron Clinical · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130920 | CORRECT PLUS 1 | Pentron Clinical | 2013-07-02 | 90 | 0 |
| K120013 | TEMPSPAN CLEAR MATRIX | Pentron Clinical | 2012-05-22 | 140 | 0 |
| K111431 | B1P ADHESIVE | Pentron Clinical | 2011-08-01 | 70 | 0 |
| K102703 | BUILD-IT TOTAL CORE | Pentron Clinical | 2011-01-05 | 107 | 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