510(k) · Cleared

Cleared

HeartFocus (V.1.1.1)

K242807510(k) TraditionalCleared Apr 4, 2025199-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

Deski · QJU Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Cleared on Apr 4, 2025 as substantially equivalent to DEN190040 (Bay Labs, Inc., 2020) after a 199-day review. Its family tree reaches back 1 generation to 2020. 1 later device descends from it.

Decided: Apr 4, 2025
Review: 199 days
Class: Class II
Product code: QJU
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN190040 (2020). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN190040 Caption GuidanceBay Labs, Inc. · 2020
This deviceK242807 HeartFocus (V.1.1.1)Deski · 2025
Descendant · cites it directly · 0 of its ownK260780 HeartFocusDeski · 2026

Most influential descendants

Showing 1 of 1 · See all

K260780HeartFocusDeski · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN190040	Caption Guidance	Bay Labs, Inc.	2020	—
0 (this device)	K242807	HeartFocus (V.1.1.1)	Deski	2025	—
+1	K260780	HeartFocus	Deski	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2026	1	0

FIG. 1 — Lineage of K242807, 2020–2026Source: 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 K260780 HeartFocusscore 11.7 · 2 generations · 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
*	DEN190040	Caption Guidance Summary page 5 …telligence Regulation Number 892.2100 Product Code QJU Legally Marketed Predicate Device DEN190040 Caption Guidance DEVICE DESCRIPTION SUMMARY The HeartFocus software is a radiological computer-assisted acquisition guidance…	Bay Labs, Inc.	2020	—

Also cleared against DEN190040: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K260780	HeartFocus	Deski	2026	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?

Its one ancestor has no recall.
Of its descendants, K260780 (Deski, 2026) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate DEN190040.

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?

Read the full statement (107 words)

The HeartFocus software is intended to assist and guide medical professionals in the acquisition of cardiac ultrasound images. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. Heartfocus guides the acquisition of two-dimensional transthoracic echocardiography (2D-TTE). 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 (A4C), Apical 5-Chamber (A5C), Apical 2-Chamber (A2C), Apical 3-Chamber (A3C), Subcostal 4-Chamber (SC-4C), and Subcostal inferior Vena Cava (SC-IVC).

HeartFocus software is indicated for use in adult patients who require a cardiac ultrasound exam.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K242807 · printed Nov 5, 2026

Cite this page

510(k) Report. “K242807: HeartFocus (V.1.1.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242807

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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