De Novo · Granted
GrantedCaption Guidance
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bay Labs, Inc. · QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Granted on Feb 7, 2020 as a new device type through De Novo after a 164-day review. 7 later devices descend from it.
- Decided
- Feb 7, 2020
- Review
- 164 days
- Class
- Class II
- Product code
- QJU
- Recalls
- None
7 later devices descend from it, 4 citing it directly.
- This deviceDEN190040 Caption GuidanceBay Labs, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK200755 Caption GuidanceCaption Health · 2020
- Descendant · cites it directly · 1 of its ownK242807 HeartFocus (V.1.1.1)Deski · 2025
- Descendant · 2 generations on · 1 of its ownK201992 Caption GuidanceCaption Health · 2020
- Descendant · cites it directly · 0 of its ownK260338 ThinkSono GuidanceThinkSono GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK260780 HeartFocusDeski · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K200755Caption GuidanceCaption Health · 2020 · cites it directly2descendants
- K242807HeartFocus (V.1.1.1)Deski · 2025 · cites it directly1descendant
- K201992Caption GuidanceCaption Health · 2020 · 2 generations on1descendant
- K260338ThinkSono GuidanceThinkSono GmbH · 2026 · cites it directly0descendants
- K260780HeartFocusDeski · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190040 | Caption Guidance | Bay Labs, Inc. | 2020 | — |
| +1 | K200755 | Caption Guidance | Caption Health | 2020 | — |
| +1 | K242807 | HeartFocus (V.1.1.1) | Deski | 2025 | — |
| +2 | K201992 | Caption Guidance | Caption Health | 2020 | — |
| +1 | K260338 | ThinkSono Guidance | ThinkSono GmbH | 2026 | — |
| +2 | K260780 | HeartFocus | Deski | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K200755 (Caption Health, 2020) has gone furthest, with 2 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. 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 (100 words)
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. 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/DEN190040 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190040: Caption Guidance.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190040
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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