Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jack W. Kindberg — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K770074 | BIO-DYES FORTIFIED HEMATOLOGY STAIN | Jack W. Kindberg | 1977-03-22 | 68 | 0 |
| K770075 | BIO-DYES HEMATOLOGY PHOSPHATE | Jack W. Kindberg | 1977-03-22 | 68 | 0 |
| K770076 | BIO-DYES FORT. WRIGHTS STAIN HEMAT. PACK | Jack W. Kindberg | 1977-03-22 | 68 | 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