Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Squibb Diagnostics — 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) |
|---|---|---|---|---|---|
| K883609 | ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR | Squibb Diagnostics | 1989-04-14 | 235 | 0 |
| K842568 | RADIONUCLIDE INFUSION SYSTEM | Squibb Diagnostics | 1984-10-19 | 109 | 0 |
| K823755 | BICEPS ELECTROCAUTERY SYSTEM | Squibb Diagnostics | 1983-01-26 | 43 | 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