Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PQZ — 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) |
|---|---|---|---|---|---|
| K173903 | Granada Medium | Hardy Diagnostics | 2018-03-22 | 90 | 0 |
| K170586 | Strep B Carrot Broth One-Step | Hardy Diagnostics | 2017-05-22 | 83 | 0 |
| K170481 | Strep B Carrot Broth Kit | Hardy Diagnostics | 2017-05-16 | 89 | 0 |
| K163042 | chromID Strepto B agar | bioMerieux, Inc. | 2017-01-27 | 88 | 1 |
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