510(k) · Cleared

Cleared

iBreastExam

K142926510(k) AbbreviatedCleared Apr 23, 2015197-day reviewClass II21 CFR 884.2990

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

Ue Lifesciences, Inc. · NKA System, Documentation, Breast Lesion

Cleared on Apr 23, 2015 as substantially equivalent to DEN020001 (Assurance Medical, 2003) after a 197-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: Apr 23, 2015
Review: 197 days
Class: Class II
Product code: NKA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN020001 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN020001 Breastview Visual Mapping SystemAssurance Medical · 2003
This deviceK142926 iBreastExamUe Lifesciences, Inc. · 2015
Descendant · cites it directly · 0 of its ownK190575 iBreastExamUe Lifesciences, Inc. · 2019

Most influential descendants

Showing 1 of 1 · See all

K190575iBreastExamUe Lifesciences, Inc. · 2019 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN020001	Breastview Visual Mapping System	Assurance Medical	2003	—
0 (this device)	K142926	iBreastExam	Ue Lifesciences, Inc.	2015	—
+1	K190575	iBreastExam	Ue Lifesciences, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0

FIG. 1 — Lineage of K142926, 2003–2019Source: 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 NKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	DEN020001	Breastview Visual Mapping System Our reading of the summary gave K010514, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN020001, Breastview Visual Mapping System (Assurance Medical), granted Jan 31, 2003; older De Novo requests were first filed under a 510(k) number, so this links to the grant.	Assurance Medical	2003	—

Also cleared against DEN020001: 1 other device →

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
K190575	iBreastExam	Ue Lifesciences, Inc.	2019	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, K190575 (Ue Lifesciences, Inc., 2019) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate DEN020001.

How does its category compare?

All NKA devices

NKA System, Documentation, Breast Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · NKA

2in 2019

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKA

Too few NKA 510(k)s in any year since 2007 to give a median.

Recalls per year · NKA

No recall names NKA since 2007.

Adverse event reports per year · NKA

No MAUDE report names NKA 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	1	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	2	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

iBreastExam™ device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam™ device is intended for use by a qualified healthcare professional trained in its use and is not for home use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K142926 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142926: iBreastExam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142926

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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