Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wieslab AB — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
104 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981748 | WIELISA ANCA SCREENING KIT TEST SYSTEM | Wieslab AB | 1998-07-22 | 65 | 0 |
| K981750 | WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM | Wieslab AB | 1998-07-22 | 65 | 0 |
| K974166 | WIELISA MPO ANCA TEST SYSTEM | Wieslab AB | 1998-02-17 | 104 | 0 |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | Wieslab AB | 1998-02-17 | 104 | 0 |
| K974167 | WIELISA PR-3 ANCA TEST SYSTEM | Wieslab AB | 1998-02-17 | 104 | 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