Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
NST · 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) |
|---|---|---|---|---|---|
| K091468 | IVD TECHNOLOGIES ACHRAB TEST KIT | Ivd Technologies | 2009-11-20 | 186 | 0 |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) | Kronus Market Development Associates, Inc. | 2008-06-17 | 112 | 0 |
| K051144 | ACETYLCHOLINE RECEPTOR AB (ARAB)RRA | Ibl-Hamburg GmbH | 2005-11-18 | 198 | 0 |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSA | Kronus Market Development Associates, Inc. | 2004-12-17 | 120 | 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