Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OGZ — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
188 daysmedian FDA review time
268 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241576 | Makoto Intravascular Imaging Systemâ„¢ (VC-MC10 / TVC-MC10i); | Infraredx, Inc. | 2025-02-26 | 268 | 0 |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Ima | Infraredx, Inc. | 2019-04-12 | 107 | 0 |
| K163345 | TVC Imaging System, TVC Catheter | Infraredx, Inc. | 2017-06-21 | 204 | 0 |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-11-24 | 154 | 0 |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2014-04-23 | 124 | 0 |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | Infraredx, Inc. | 2013-10-17 | 213 | 0 |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | 2013-03-15 | 163 | 0 |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | Infraredx, Inc. | 2010-06-30 | 188 | 0 |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | Infraredx, Inc. | 2008-04-25 | 192 | 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