Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ICL — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | Alpha-Tec Systems, Inc. | 1989-01-24 | 11 | 0 |
| K842933 | CARBOL-FUCHSIN, ZIEHL-NEEDSEN | E K Ind., Inc. | 1984-09-11 | 48 | 0 |
| K792483 | STAINS, COUNTERSTAINS & GEN. PURPOSE | Laboratory Products, Inc. | 1979-12-18 | 29 | 0 |
| K771390 | HISTOCHEMICAL AFB DEMONSTRATION | Harleco | 1977-08-22 | 26 | 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