Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rolor Electronics Corp. · 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) |
|---|---|---|---|---|---|
| K020130 | ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M | Rolor Electronics Corp. | 2002-12-02 | 321 | 0 |
| K021430 | SANIDAD TENS-DUO MODE GP8016N | Rolor Electronics Corp. | 2002-12-02 | 213 | 0 |
| K020464 | SANIDAD FAR-INFRARED MINI LAMP, MODEL FI-3646 | Rolor Electronics Corp. | 2002-09-17 | 217 | 0 |
| K020462 | SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018 | Rolor Electronics Corp. | 2002-09-16 | 216 | 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