Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Relievant Medsystems — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

142 daysmedian FDA review time
240 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190504Intracept Intraosseous Nerve Ablation System (RF Probe), IntRelievant Medsystems2019-05-03630
K180369Intracept Intraosseous Nerve Ablation System (component IntrRelievant Medsystems2018-09-142140
K171143Relievant Medsystems RF GeneratorRelievant Medsystems2017-08-181220
K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems2017-08-091420
K153272INTRACEPT Flexible Bi-Polar RF Probe and Easy Access InstrumRelievant Medsystems2016-07-092400
K100641INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMRelievant Medsystems2010-03-30250

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