Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
KEA — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
38 daysmedian FDA review time
252 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890997 | ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC) | Atlantic Wholesale, Inc. | 1989-03-28 | 29 | 0 |
| K844948 | SYVA SOLID PHASE COLUMNS | Syva Co. | 1985-08-29 | 252 | 0 |
| K842028 | CM-TRISACRYL M DEAE-TRISACRYL M | Lkb Instruments, Inc. | 1984-06-07 | 20 | 0 |
| K833320 | AMBERLITE CG50 RESIN, 100-200 MESH | Biosan Laboratories, Inc. | 1983-12-08 | 73 | 0 |
| K833319 | BIO-REX 70 RESIN 100-200 MESH PH6.2 | Biosan Laboratories, Inc. | 1983-11-03 | 38 | 0 |
| K831027 | EXTRELUT QE EXTRACTION COLUMNS | Emd Chemicals, Inc. | 1983-05-16 | 47 | 0 |
| K830918 | I.E.C COLUMN | Berwick Medical Products, Inc. | 1983-04-27 | 36 | 0 |
| K782066 | EXETRELUT | Mcb Manufacturing Chemists, Inc. | 1979-01-03 | 21 | 0 |
| K781728 | EXTUBE | Analytichem International, Inc. | 1978-12-20 | 75 | 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