Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Foley & Lardner — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
204 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973613 | CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PR | Foley & Lardner | 1998-04-14 | 204 | 0 |
| K942309 | DYNASTY U1-31 (GELL/CELL) | Foley & Lardner | 1994-11-07 | 178 | 0 |
| K942310 | DYNASTY GC 12550 (GELL/CELL) | Foley & Lardner | 1994-11-07 | 178 | 0 |
| K942308 | DYNASTY GC 12400 (GELL/CELL) | Foley & Lardner | 1994-11-07 | 178 | 0 |
| K942311 | DYNASTY U1-33 AGM | Foley & Lardner | 1994-11-07 | 178 | 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