510(k) · Cleared

Cleared

Cardiac Guidance

K243065510(k) TraditionalCleared Jan 15, 2025110-day reviewClass II21 CFR 892.2100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Caption Health, Inc. · QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Cleared on Jan 15, 2025 as substantially equivalent to K201992 (Caption Health, 2020) after a 110-day review. Its family tree reaches back 3 generations to 2020.

Decided: Jan 15, 2025
Review: 110 days
Class: Class II
Product code: QJU
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN190040 (2020). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backDEN190040 Caption GuidanceBay Labs, Inc. · 2020
2 generations backK200755 Caption GuidanceCaption Health · 2020
1 generation backK201992 Caption GuidanceCaption Health · 2020
This deviceK243065 Cardiac GuidanceCaption Health, Inc. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	DEN190040	Caption Guidance	Bay Labs, Inc.	2020	—
−2	K200755	Caption Guidance	Caption Health	2020	—
−1	K201992	Caption Guidance	Caption Health	2020	—
0 (this device)	K243065	Cardiac Guidance	Caption Health, Inc.	2025	—

FIG. 1 — Lineage of K243065, 2020–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K201992	Caption Guidance Summary page 6 …Technological Characteristics compared to the previously-cleared PCCP: The updated PCCP expands upon the existing list of changes from the most recent 510(k) clearance (K201992). Performance Data and Performance Testing Safety and performance of the Cardiac Guidance software will be evaluated and verifie…	Caption Health	2020	—

What descends from it?

No later submission names this one as a predicate yet.

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 5 years and passes through 3 companies; a new generation was cleared every 5 months on median.
None of the 3 ancestors has a recall.

How does its category compare?

All QJU devices

QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · QJU

3in 2025

2007high 3 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJU

199in 2025

2007high 199 (2025)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	3	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	3	199	0
2026	3	163	—

What is it indicated for?

The Cardiac Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. The Cardiac Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. The Cardiac 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 Cardiac 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/K243065 · printed Nov 5, 2026

Cite this page

510(k) Report. “K243065: Cardiac Guidance.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243065

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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