Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
The Surgical Company International B.V. · 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) |
|---|---|---|---|---|---|
| K252636 | Fluido Compact System | The Surgical Company International B.V. | 2025-11-18 | 90 | 0 |
| K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023-06-05 | 740 | 0 |
| K101705 | MISTRAL-AIR WARMING SYSTEM | The Surgical Company International B.V. | 2010-07-02 | 15 | 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