Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NJW — Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220163 | Her-2, ER, PR IHControls | Boston Cell Standards, Inc. | 2022-08-15 | 207 | 0 |
| K023335 | QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) | Qc Sciences, LLC | 2003-06-18 | 254 | 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