510(k) Report

FDA applicant

HeartLung Corporation

Houston, TX3 decisions2022–20250 recalls

FDA records 3 decisions for HeartLung Corporation (Houston, TX) from 2022 to 2025: 3 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and KGI (Densitometer, Bone). Its devices cite 5 predicates, 2 of them its own earlier devices. No 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, radiology panel, where it files most

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

FDA decisions per year

1in 2025

2022: 12024: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — HeartLung Corporation by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software2decisions
  • KGIDensitometer, Bone1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K213760ABMD SoftwareHeartLung Corporation · 20222cite it
  • K240786AutoChamberHeartLung Corporation · 20241cites it

What has FDA decided for it lately?

  • K252029AI-CVDHeartLung Corporation · 2025
  • K240786AutoChamberHeartLung Corporation · 2024
  • K213760ABMD SoftwareHeartLung Corporation · 2022

All 3 as HeartLung Corporation →