510(k) · Cleared

Cleared

Clarius Prostate AI

K243853510(k) TraditionalCleared Apr 16, 2025121-day reviewClass II21 CFR 892.2050

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

Clarius Mobile Health Corp. · QIH Automated Radiological Image Processing Software

Cleared on Apr 16, 2025 as substantially equivalent to K232257 (Clarius Mobile Health Corp., 2023) after a 121-day review. Its family tree reaches back 3 generations to 2021.

Decided: Apr 16, 2025
Review: 121 days
Class: Class II
Product code: QIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K203502 (2021). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK203502 MEDO-ThyroidMedo DX Pte., Ltd. · 2021
2 generations backK230497 Bladder AI (AIBV01)Exo, Inc. · 2023
1 generation backK232257 Clarius Bladder AIClarius Mobile Health Corp. · 2023
This deviceK243853 Clarius Prostate AIClarius Mobile Health Corp. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K203502	MEDO-Thyroid	Medo DX Pte., Ltd.	2021	—
−2	K230497	Bladder AI (AIBV01)	Exo, Inc.	2023	—
−1	K232257	Clarius Bladder AI	Clarius Mobile Health Corp.	2023	—
0 (this device)	K243853	Clarius Prostate AI	Clarius Mobile Health Corp.	2025	—

FIG. 1 — Lineage of K243853, 2021–2025Source: 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 QIH? 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 QIH device

#1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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
*	K232257	Clarius Bladder AI Summary page 5 …April 11, 2025 Predicate Device Information: Device Trade Name: Clarius Bladder AI 510(k) Reference: K232257 Manufacturer Name: Clarius Mobile Health Corp. Regulation Name: Medical…	Clarius Mobile Health Corp.	2023	—
†	K193283	AI-Rad Companion Prostate MR	Siemens Medical Solutions USA, Inc.	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 4 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All QIH devices

QIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · QIH

94in 2025

2007high 94 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QIH

150in 2025

2007high 151 (2023) · low 125 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QIH

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QIH

4in 2025

2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.

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	2	—	0	0
2020	11	145	0	0
2021	19	125	0	0
2022	25	134	0	0
2023	45	151	0	0
2024	64	141	0	2
2025	94	150	0	4
2026	78	130	1	—

What is it indicated for?

Clarius Prostate AI is intended for semi-automatic measurements of prostate volume on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., curvilinear and endo-cavitary scanners). The user shall be a healthcare professional trained and qualified in ultrasound. The user retains the responsibility of confirming the validity of the measurements based on standard practices and clinical judgment. Clarius Prostate AI is intended for use in adult male patients only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K243853 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243853: Clarius Prostate AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243853

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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