Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Squibb & Sons, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
18 daysmedian FDA review time
34 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K821174 | TSH-SQUIBB RADIOIMMUNOASSAY KIT | Squibb & Sons, Inc. | 1982-05-14 | 18 | 0 |
| K801424 | ESTRIOL RIA KIT FOR USE WITH GAMMAFLO | Squibb & Sons, Inc. | 1980-07-21 | 34 | 0 |
| K800750 | STOMAHESIVE STERILE WAFER | Squibb & Sons, Inc. | 1980-05-08 | 34 | 0 |
| K770726 | RIA KIT, T4 CLASP | Squibb & Sons, Inc. | 1977-04-28 | 9 | 0 |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | Squibb & Sons, Inc. | 1976-12-30 | 14 | 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