Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KTS · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813508 | SAC-CEL | Burroughs Wellcome Co. | 1981-12-29 | 14 | 0 |
| K792636 | CENTRIA RADIOIMMUNOASSAY SEPARATION | Union Carbide Corp. | 1980-01-11 | 22 | 0 |
| K792637 | CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) | Union Carbide Corp. | 1980-01-11 | 22 | 0 |
| K781070 | SECOND ANTIBODY | Pcl-Ria, Inc. | 1978-08-10 | 45 | 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