Caption Health: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Caption Health” (first 2020, latest 2025), plus 1 De Novo decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 110 days. Since 2017 the median was 110 days, against 140 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 3 | 63 |
| 2021 | 0 | — |
| 2022 | 1 | 313 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 110 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Caption Health took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QJU | Image Acquisition And/Or Optimization Guided By Artificial Intelligence | 3 | 3 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| QVD | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan | 1 | 0 |
Review panels
- Radiology (6)
Most recent Caption Health 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243065 | Cardiac Guidance | QJU | 2025-01-15 | 110 |
| K210747 | Caption Interpretation Automated Ejection Fraction Software | QIH | 2022-01-19 | 313 |
| K201992 | Caption Guidance | QJU | 2020-09-18 | 63 |
| K200621 | Caption Interpretation Automated Ejection Fraction Software | QIH | 2020-07-22 | 135 |
| K200755 | Caption Guidance | QJU | 2020-04-16 | 24 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220063 | De Novo | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan | 2023-02-24 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-05-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Caption Health is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06717373: Point-of-Care Echocardiography in Patients with Known or Suspected Aortic Stenosis (Recruiting, started 2025-02-07)
- NCT05992324: A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation (Recruiting, started 2023-07-17)
Frequently asked questions
How many FDA 510(k) clearances are listed under Caption Health?
FDA lists 5 510(k) clearances under the applicant name “Caption Health” (first 2020, latest 2025), plus 1 De Novo decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Caption Health?
The median time from FDA receipt to decision across 510(k)s cleared under the name Caption Health is 110 days. Since 2017: 110 days, versus 140 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Caption Health?
The most frequent FDA product codes under this applicant name are QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence, 3); QIH (Automated Radiological Image Processing Software, 2); QVD (Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan, 1).
Next steps
- See all 5 Caption Health clearances with predicates and recalls
- Run predicate analysis for product code QJU, Caption Health's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.