Infraredx, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Infraredx, Inc.” (first 2006, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 188 days. Since 2017 the median was 156 days, against 128 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 188 |
| 2014 | 2 | 139 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 204 |
| 2018 | 0 | — |
| 2019 | 1 | 107 |
| 2020 | 0 | — |
| 2021 | 1 | 64 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 268 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Infraredx, Inc. took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OGZ | Catheter, Intravascular, Plaque Morphology Evaluation | 9 | 9 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Cardiovascular (10)
- Radiology (1)
Most recent Infraredx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241576 | Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) | OGZ | 2025-02-26 | 268 |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 | IYO | 2021-12-07 | 64 |
| K183599 | Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter | OGZ | 2019-04-12 | 107 |
| K163345 | TVC Imaging System, TVC Catheter | OGZ | 2017-06-21 | 204 |
| K141682 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | OGZ | 2014-11-24 | 154 |
| K133897 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | OGZ | 2014-04-23 | 124 |
| K130719 | TVC IMAGING SYSTEM, TVC INSIGHT CATHETER | OGZ | 2013-10-17 | 213 |
| K123108 | TVC IMAGING SYSTEM MODEL NIRS-MC7-70 | OGZ | 2013-03-15 | 163 |
| K093993 | LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70 | OGZ | 2010-06-30 | 188 |
| K072932 | INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 | OGZ | 2008-04-25 | 192 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-12-15.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Infraredx, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04985773: A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon (Completed, started 2021-12-17)
- NCT02154295: In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems (Completed, started 2014-05)
- NCT02033694: The Lipid-Rich Plaque Study (Completed, started 2014-02)
- NCT00905671: Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study (Completed, started 2009-06)
- NCT00901446: Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter (Completed, started 2009-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Infraredx, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Infraredx, Inc.” (first 2006, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Infraredx, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Infraredx, Inc. is 188 days. Since 2017: 156 days, versus 128 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Infraredx, Inc.?
The most frequent FDA product codes under this applicant name are OGZ (Catheter, Intravascular, Plaque Morphology Evaluation, 9); DQO (Catheter, Intravascular, Diagnostic, 1); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 11 Infraredx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OGZ, Infraredx, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.