510(k) Report

FDA applicant

Caption Health

Brisbane, CA6 decisions2020–20251 recall

FDA records 6 decisions for Caption Health (Brisbane, CA) from 2020 to 2025: 5 510(k) clearances and 1 De Novo grant. Most are in product codes QJU (Image Acquisition And/Or Optimization Guided…) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Caption Health, Inc.”.

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 Caption Health’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 32022: 12023: 12025: 1
2020high 3 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2020high 1 (2021) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Caption Health by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Caption Health’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?

  • QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence3decisions
  • QIHAutomated Radiological Image Processing Software2decisions
  • QVDRadiological Machine Learning Based Quantitative Imaging Software With Change Control Plan1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 135 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 145 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 20222cite it
  • K200755Caption GuidanceCaption Health · 20201cites it
  • K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 20201cites it
  • K201992Caption GuidanceCaption Health · 20201cites it

What has FDA decided for it lately?

  • K243065Cardiac GuidanceCaption Health, Inc. · 2025
  • DEN220063Caption Interpretation Automated Ejection Fraction SoftwareCaption Health, Inc. · 2023
  • K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 2022
  • K201992Caption GuidanceCaption Health · 2020
  • K200621Caption Interpretation Automated Ejection Fraction SoftwareCaption Health · 20201 recall
  • K200755Caption GuidanceCaption Health · 2020

All 4 as Caption Health →All 2 as Caption Health, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K200621Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System…May 19, 2021Class II