510(k) · Cleared
ClearedLiv Breast Self Examination Aid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liv International USA, Inc. · IZH System, X-Ray, Mammographic
Cleared on Mar 8, 2007 as substantially equivalent to K023390 (Mbf Sales, LLC, 2002) after a 30-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 8, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K955249 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 3 generations backK973450 Sensor PadInventive Products, Inc. · 1997
- 2 generations backK991469 Aware PadAac Consulting Group, Inc. · 1999
- 1 generation backK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- This deviceK070344 Liv Breast Self Examination AidLiv International USA, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −3 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| −2 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| −1 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| 0 (this device) | K070344 | Liv Breast Self Examination Aid | Liv International USA, Inc. | 2007 | — |
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 IZH? 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 IZH device
- #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K023390 | MY Breast Friend, Breast Self-Exam PadSummary page 1…Aid is substantially equivalent to the previously cleared My Breast Friend device from MBF Sales, LLC (Rockville, MD). The predicate 510(k) number is K023390. Liv International USA, Inc. Page 2 of 3… | 2002 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K023390.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IZH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · IZH
64in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZH
15in 2025
MAUDE reports naming product code IZH, 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 | 3 | 30 | 0 | 11 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 3 | 64 | 0 | 9 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Liv TM Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070344: Liv Breast Self Examination Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070344
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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