Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hogan Lovells US LLP · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K122358 | NOVEON | Hogan Lovells US LLP | 2014-03-11 | 585 | 0 |
| K132287 | JAZZ SYSTEM | Hogan Lovells US LLP | 2013-09-25 | 64 | 0 |
| K120564 | CALYPSO SYSTEM | Hogan Lovells US LLP | 2012-07-16 | 143 | 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