Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DII · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
35 daysmedian FDA review time
58 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874824 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | 1988-01-21 | 58 | 0 |
| K862542 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | 1986-08-04 | 32 | 0 |
| K844164 | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A | Lkb Instruments, Inc. | 1984-12-10 | 46 | 0 |
| K841712 | CAPILLARY GAS CHROMATOGRAPHIC COLUMNS | Supelco, Inc. | 1984-05-21 | 27 | 0 |
| K791893 | 19091-XXXXX SER. OF GLASS CAPILLARY COL. | Hewlett-Packard Co. | 1979-10-30 | 35 | 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