510(k) · Cleared
ClearedCaption Guidance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caption Health · QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Cleared on Sep 18, 2020 as substantially equivalent to K200755 (Caption Health, 2020) after a 63-day review. Its family tree reaches back 2 generations to 2020. 1 later device descends from it.
- Decided
- Sep 18, 2020
- Review
- 63 days
- Class
- Class II
- Product code
- QJU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN190040 (2020). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K243065Cardiac GuidanceCaption Health, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN190040 | Caption Guidance | Bay Labs, Inc. | 2020 | — |
| −1 | K200755 | Caption Guidance | Caption Health | 2020 | — |
| 0 (this device) | K201992 | Caption Guidance | Caption Health | 2020 | — |
| +1 | K243065 | Cardiac Guidance | Caption Health, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QJU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QJU device
- #1 K242807 HeartFocus (V.1.1.1)score 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200755 | Caption GuidanceSummary page 4…lassification Name: Image Acquisition And/Or Optimization Guided By Artificial Intelligence Regulatory Class: II Product Code: QJU Predicate Device: Caption Guidance (K200755) Device Description: The Caption Guidance software is a radiological computer assisted acquisition guidance system that provide… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243065 | Cardiac Guidance | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 0 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243065 (Caption Health, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QJU devicesQJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QJU
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJU
199in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJU
No recall names QJU since 2007.
Adverse event reports per year · QJU
No MAUDE report names QJU since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 3 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 199 | 0 | 0 |
| 2026 | 3 | 163 | 0 | — |
What is it indicated for?
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX)…
Read the full statement (101 words)
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems.
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201992 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201992: Caption Guidance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201992
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026