# Caption Health

- Location (FDA's records): Brisbane, CA
- FDA decisions: 6 (2020–2025): 5 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Caption Health (4); Caption Health, Inc. (2)
- Product codes: QJU (3), QIH (2), QVD (1)
- 510(k) review time since 2016: median 135 days, against 145 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 5 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bay Labs, Inc.: 2 (https://510kreport.com/company/bay-labs)

## Firms that cite its devices most
- Clarius Mobile Health Corp.: 1 (https://510kreport.com/company/clarius-mobile-health)
- InVision Medical Technology Corporation: 1 (https://510kreport.com/company/invision-medical-technology)

## Its most-cited devices
- K210747: Caption Interpretation Automated Ejection Fraction Software (2022), cited by 2
- K200755: Caption Guidance (2020), cited by 1
- K200621: Caption Interpretation Automated Ejection Fraction Software (2020), cited by 1
- K201992: Caption Guidance (2020), cited by 1

## Recent decisions
- K243065: Cardiac Guidance (Jan 15, 2025)
- DEN220063: Caption Interpretation Automated Ejection Fraction Software (Feb 24, 2023)
- K210747: Caption Interpretation Automated Ejection Fraction Software (Jan 19, 2022)
- K201992: Caption Guidance (Sep 18, 2020)
- K200621: Caption Interpretation Automated Ejection Fraction Software (Jul 22, 2020)
- K200755: Caption Guidance (Apr 16, 2020)

Source page: https://510kreport.com/company/caption-health