Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NLG — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2021-12-20 | 110 | 0 |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping Cathete | Innovative Health, LLC | 2021-11-18 | 170 | 0 |
| K190785 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Innovative Health, LLC | 2019-06-25 | 90 | 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