Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gentuity, LLC — 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) |
|---|---|---|---|---|---|
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Ima | Gentuity, LLC | 2025-01-31 | 127 | 1 |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G1 | Gentuity, LLC | 2024-08-16 | 17 | 0 |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging C | Gentuity, LLC | 2023-08-08 | 155 | 0 |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Cat | Gentuity, LLC | 2020-02-20 | 127 | 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