Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stedim, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911567 | DUAL COMPARTMENT TPN BAG 3 LITER | Stedim, Inc. | 1991-08-02 | 115 | 0 |
| K890205 | AUTOMIX COMPOUNDER Y - ADAPTOR SET | Stedim, Inc. | 1989-10-27 | 282 | 0 |
| K890204 | AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR | Stedim, Inc. | 1989-10-27 | 282 | 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