Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sanyo Electric, 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) |
|---|---|---|---|---|---|
| K850449 | DIGITAL PULSE METER HRM-100E & ETC. | Sanyo Electric, Inc. | 1986-12-04 | 667 | 0 |
| K822692 | DIGITAL PULSE METER (73 BWS) #HRM-100E | Sanyo Electric, Inc. | 1982-10-15 | 38 | 0 |
| K822768 | ELECTROCARDIOGRAPH (74 DPS) #YM-102 | Sanyo Electric, Inc. | 1982-10-04 | 20 | 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