510(k) Report

FDA applicant

Track X Technology, LLC

Durham, NC2 decisions2018–20202 recalls

FDA records 2 decisions for Track X Technology, LLC (Durham, NC) from 2018 to 2020: 2 510(k) clearances. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Its devices cite 2 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

How often FDA has decided Track X Technology, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

1in 2024

2022: 12024: 1
2018high 1 (2022) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Track X Technology, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K173736TrackXTrack X Technology, LLC · 20182cite it
  • K200360TrackXTrack X Technology, LLC · 20202cite it

What has FDA decided for it lately?

  • K200360TrackXTrack X Technology, LLC · 20202 recalls
  • K173736TrackXTrack X Technology, LLC · 20182 recalls

All 2 as Track X Technology, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K173736Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap…Sep 3, 2024Class III
  • K200360TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX…Oct 24, 2022Class II

Other applicant names beginning “Track”

FDA records each applicant name separately; these may or may not be the same firm.

Track Corporation 1