Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
H.W. Andersen Products, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
396 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935688 | AN-10S ANDERSEN TUBE WITH STYLET | H.W. Andersen Products, Inc. | 1994-12-30 | 396 | 0 |
| K872458 | AN3200 DOUBILET DRAIN | H.W. Andersen Products, Inc. | 1987-09-21 | 90 | 0 |
| K872460 | AN3000 MAHONEY DRAIN | H.W. Andersen Products, Inc. | 1987-07-23 | 30 | 0 |
| K872459 | AN3100 MULHOLLAND DRAIN | H.W. Andersen Products, Inc. | 1987-07-21 | 28 | 0 |
| K872457 | AN3500 WORTH DRAIN | H.W. Andersen Products, Inc. | 1987-07-21 | 28 | 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