Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
JBF · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
295 daysmedian FDA review time
876 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201049 | FINDER G6PD | Baebies, Inc. | 2022-09-14 | 876 | 0 |
| K161364 | BinaxNOW G6PD Test | Alere Scarborough, Inc. | 2016-06-17 | 31 | 0 |
| K080003 | BINAXNOW G6PD TEST | Binax, Inc. | 2008-10-23 | 295 | 0 |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | Pointe Scientific, Inc., | 2003-03-31 | 117 | 1 |
| K933934 | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST | Sigma Diagnostics, Inc. | 1995-06-29 | 687 | 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