Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KJC — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880509 | MULTISURFACE ROLLER BOTTLE (M.S.R.B.) | Motil Plastics , Ltd. | 1988-04-01 | 51 | 0 |
| K873137 | IN VITRO 2.5X ROLLER BOTTLE | In Vitro Scientific Products | 1987-08-24 | 14 | 0 |
| K791049 | SYNALON ROLLER BOTTLE | Dynatech Laboratories, Inc. | 1979-06-28 | 22 | 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