Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Renesco International, 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) |
|---|---|---|---|---|---|
| K800659 | SCHILLER MSG-1 | Renesco International, Inc. | 1980-04-08 | 13 | 0 |
| K791422 | MINISPIROMETER SP-1 | Renesco International, Inc. | 1979-11-05 | 112 | 0 |
| K791421 | MINISCOPE MS-2B ELECTROCARDIOSCOPE | Renesco International, Inc. | 1979-08-28 | 43 | 0 |
| K791420 | MINIGRAPH MG-I ELECTROCARDIOGRAPH | Renesco International, Inc. | 1979-08-28 | 43 | 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