Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PMU · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250212 | LapBox Power Tissue Containment System | Ark Surgical | 2025-04-15 | 81 | 0 |
| K212659 | More-Cell-System | Agency For Medical Innovations GmbH | 2021-11-10 | 79 | 0 |
| K192898 | PneumoLiner | Advanced Surgical Concepts | 2020-02-25 | 137 | 0 |
| DEN150028 | PneumoLiner | Advanced Surgical Concepts, Ltd. | 2016-04-07 | 293 | 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