Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neuro Resource Group, 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) |
|---|---|---|---|---|---|
| K130816 | INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) | Neuro Resource Group, Inc. | 2013-06-21 | 88 | 0 |
| K070217 | INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE | Neuro Resource Group, Inc. | 2008-04-04 | 437 | 0 |
| K053626 | INTERX500 FLEXIBLE ARRAY ELECTRODE | Neuro Resource Group, Inc. | 2006-03-29 | 91 | 0 |
| K042912 | INTERX5000 | Neuro Resource Group, Inc. | 2005-05-17 | 208 | 1 |
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