Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JXC — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
204 daysmedian FDA review time
265 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960075 | CHROMAGAR CANDIDA | Hardy Diagnostics | 1996-08-02 | 204 | 0 |
| K913426 | ALBICANS SURE | Jrga Diagnostics | 1992-04-22 | 265 | 0 |
| K884720 | GERM TUBE SOLUTION | Remel Co. | 1989-06-02 | 204 | 0 |
| K891476 | C. ALBICANS SCREEN | Carr-Scarborough Microbiologicals, Inc. | 1989-04-12 | 27 | 0 |
| K882371 | SOC SLIDE CULTURE SYSTEM | The Cancer Center AT Wadley Institutes | 1988-07-18 | 40 | 0 |
| K832406 | QUANTUM II YEAST IDENT. SYSTEM | Abbott Laboratories | 1983-09-26 | 67 | 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