510(k) · Cleared
ClearediBreastExam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ue Lifesciences, Inc. · NKA System, Documentation, Breast Lesion
Cleared on Jul 16, 2019 as substantially equivalent to K142926 (Ue Lifesciences, Inc., 2015) after a 132-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Jul 16, 2019
- Review
- 132 days
- Class
- Class II
- Product code
- NKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN020001 (2003). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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
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 | Decided |
|---|---|---|---|
| * | K142926 | iBreastExamSummary page 4…assification Name Breast Lesion Documentation System Product Code NKA Regulatory Class Class II Predicate Device(s) iBreastExam (K142926) The predicate device has not been subject to any design related recalls.… | 2015 |
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 16 years and passes through 2 companies; a new generation was cleared every 12.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NKA devicesNKA System, Documentation, Breast Lesion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · NKA
2in 2019
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 | 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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
iBreastExam Gen II 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 Gen II device is intended for use by a qualified healthcare professional trained in its use and is not for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190575: iBreastExam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190575
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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