Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Medical Systems 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) |
|---|---|---|---|---|---|
| K791834 | NURITE II VRM DUAL (ELEC. NERVE STIM.) | Bio-Medical Systems Corp. | 1979-10-02 | 15 | 0 |
| K791833 | NURITE II VRM SINGLE (ELEC. NERVE STIM) | Bio-Medical Systems Corp. | 1979-10-02 | 15 | 0 |
| K781683 | NURITE II, SINGLE | Bio-Medical Systems Corp. | 1978-10-13 | 11 | 0 |
| K780828 | NURITE II | Bio-Medical Systems Corp. | 1978-05-31 | 12 | 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