Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Andersen Products, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K021493 | ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 1 | Andersen Products, Inc. | 2002-08-30 | 113 | 0 |
| K011077 | ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) | Andersen Products, Inc. | 2001-05-09 | 30 | 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