Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KJF — 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) |
|---|---|---|---|---|---|
| K893787 | LIFECELL RECOVERY CONTAINER | Baxter Healthcare Corp | 1989-06-23 | 32 | 0 |
| K892645 | AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY | Amicon, Inc. | 1989-06-13 | 62 | 0 |
| K875221 | TOOTH PRESERVING SYSTEM | Biological Rescue Products, Inc. | 1988-04-14 | 114 | 0 |
| K780305 | CELL | Dynatech Laboratories, Inc. | 1978-03-27 | 32 | 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