Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Relievant Medsystems, 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) |
|---|---|---|---|---|---|
| K222281 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-10-26 | 89 | 1 |
| K213836 | Intracept Intraosseous Nerve Ablation System | Relievant Medsystems, Inc. | 2022-03-11 | 92 | 0 |
| K083856 | INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT S | Relievant Medsystems, Inc. | 2009-01-22 | 29 | 0 |
| K070443 | INTRACEPT BI-POLAR RF PROBE, MODEL 04814 | Relievant Medsystems, Inc. | 2007-10-05 | 232 | 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