510(k) · Cleared
ClearedIntraredx Nir Imaging System, Model MC-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infraredx, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jun 23, 2006 after a 252-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 252 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK052908 Intraredx Nir Imaging System, Model MC-5Infraredx, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK072932 Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK093510 Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK093993 Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K072932Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc. · 2008 · cites it directly1descendant
- K093510Lumenvu Catheter Guidance SystemSonosite,Inc. · 2010 · cites it directly0descendants
- K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052908 | Intraredx Nir Imaging System, Model MC-5 | Infraredx, Inc. | 2006 | — |
| +1 | K072932 | Infraredix Nir Imaging System, Gen. 1.0, Model MC-5 | Infraredx, Inc. | 2008 | — |
| +1 | K093510 | Lumenvu Catheter Guidance System | Sonosite,Inc. | 2010 | — |
| +2 | K093993 | Lipiscan Ivus Imaging System Model Nirs-MC7-70 | Infraredx, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Boston Scientific Galaxy IVUS System Named without a submission number | |
| * | — | Boston Scientific Atlantis SR, SR Pro and SR Plus IVUS catheter Named without a submission number | |
| * | — | Volcano Revolution and Eagle Eye Gold IVUS catheter, IVUS system Named without a submission number | |
| * | — | Baxter Imagecath Coronary Angioscope Named without a submission number | |
| * | — | American Edwards Angioscopy catheter/system Named without a submission number | |
| * | — | Cardio-Optics CSA System Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072932 (Infraredx, Inc., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The InfraReDx NIR System is intended for the near infrared imaging of the coronary arteries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052908 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052908: Intraredx Nir Imaging System, Model MC-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052908
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026