Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Axis-Shield Poc AS — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132031 | AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL | Axis-Shield Poc AS | 2014-03-21 | 246 | 0 |
| K110056 | AFINION ANALYZER | Axis-Shield Poc AS | 2011-02-15 | 36 | 0 |
| K072409 | AFINION ACR AND ACR CONTROL | Axis-Shield Poc AS | 2008-02-12 | 169 | 0 |
| K050574 | AFINION HBALC | Axis-Shield Poc AS | 2005-07-22 | 137 | 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