Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vital Concepts, Inc. — 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) |
|---|---|---|---|---|---|
| K032832 | IRRIGATION SETS | Vital Concepts, Inc. | 2003-09-26 | 15 | 0 |
| K960616 | VITAFLOW SUCTION/ASPIRATION TUBING SET | Vital Concepts, Inc. | 1996-05-06 | 83 | 6 |
| K930192 | VCI INSUFLATOR FILTER W/ TUBING | Vital Concepts, Inc. | 1994-03-02 | 412 | 0 |
| K934382 | VCI SUCTION/IRRIGATION TUBING SET | Vital Concepts, Inc. | 1994-02-01 | 145 | 10 |
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