510(k) Report

FDA applicant

Infraredx, Inc.

Burlington, MA11 decisions2006–20251 recall

FDA records 11 decisions for Infraredx, Inc. (Burlington, MA) from 2006 to 2025: 11 510(k) clearances. Most are in product codes OGZ (Catheter, Intravascular, Plaque Morphology…) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 11 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Infraredx, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 12010: 12013: 22014: 22017: 12019: 12021: 12025: 1
2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Infraredx, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Infraredx, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OGZCatheter, Intravascular, Plaque Morphology Evaluation9decisions
  • DQOCatheter, Intravascular, Diagnostic1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 11 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052908Intraredx Nir Imaging System, Model MC-5Infraredx, Inc. · 20062cite it
  • K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterInfraredx, Inc. · 20192cite it
  • K072932Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc. · 20081cites it
  • K141682TVC Imaging System, TVC Insight CatheterInfraredx, Inc. · 20141cites it
  • K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42…Infraredx, Inc. · 20211cites it

What has FDA decided for it lately?

  • K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter…Infraredx, Inc. · 2025
  • K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42…Infraredx, Inc. · 2021
  • K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterInfraredx, Inc. · 2019
  • K163345TVC Imaging System, TVC CatheterInfraredx, Inc. · 2017
  • K141682TVC Imaging System, TVC Insight CatheterInfraredx, Inc. · 20141 recall
  • K133897TVC Imaging System, TVC Insight CatheterInfraredx, Inc. · 2014
  • K130719TVC Imaging System, TVC Insight CatheterInfraredx, Inc. · 2013
  • K123108TVC Imaging System Model Nirs-MC7-70Infraredx, Inc. · 2013

All 11 as Infraredx, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K141682TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary…Dec 15, 2016Class II