510(k) · Cleared
ClearedMY Breast Friend, Breast Self-Exam Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mbf Sales, LLC · IXH Camera, Focal Spot, Radiographic
Cleared on Nov 26, 2002 as substantially equivalent to K973450 (Inventive Products, Inc., 1997) and 1 other predicate after a 48-day review. Its family tree reaches back 3 generations to 1995. 21 later devices descend from it.
- Decided
- Nov 26, 2002
- Review
- 48 days
- Class
- Class I
- Product code
- IXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955249 (1995). 21 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 2 generations backK973450 Sensor PadInventive Products, Inc. · 1997
- 1 generation backK991469 Aware PadAac Consulting Group, Inc. · 1999
- This deviceK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- Descendant · cites it directly · 17 of its ownK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- Descendant · 2 generations on · 16 of its ownK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 11 of its ownK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 10 of its ownK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
- Descendant · 5 generations on · 6 of its ownK151015 ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc. · 2015 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K050602AltaireHitachi Medical Systems America, Inc. · 2005 · cites it directly17descendants
- K052172HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · 2 generations on16descendants
- K083533Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · 3 generations on11descendants
- K113145Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · 4 generations on10descendants
- K151015ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc. · 2015 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −2 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| −1 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| 0 (this device) | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| +1 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| +2 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| +3 | K083533 | Echelon C Mri System | Hitachi Medical Systems America, Inc. | 2009 | 2 |
| +4 | K113145 | Echelon Oval Mri System | Hitachi Medical Systems America, Inc. | 2012 | 3 |
| +5 | K151015 | ECHELON Oval V 5.0 MRI System | Hitachi Medical Systems America, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
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 IXH? 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? (2)
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 |
|---|---|---|---|
| * | K973450 | Sensor PadSummary page 1…tandards are applicable. 3. Substantial Equivalence: The My Breast Friend Self-exam Pad is substantially equivalent to the currently marketed devices, Sensor Pad (K973450) and Aware Pad (K991469). 4. Indications for Use: The My Breast Friend Self-exam Pad is indicated as an aid for performing br… | 1997 |
| * | K991469 | Aware PadSummary page 1…3. Substantial Equivalence: The My Breast Friend Self-exam Pad is substantially equivalent to the currently marketed devices, Sensor Pad (K973450) and Aware Pad (K991469). 4. Indications for Use: The My Breast Friend Self-exam Pad is indicated as an aid for performing breast self-examination… | 1999 |
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050602 (Hitachi Medical Systems America, Inc., 2005) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K973450.
How does its category compare?
All IXH devicesIXH Camera, Focal Spot, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXH
FDA has decided no IXH device since 2007.
Median 510(k) review, days · IXH
Too few IXH 510(k)s in any year since 2007 to give a median.
Recalls per year · IXH
No recall names IXH since 2007.
Adverse event reports per year · IXH
No MAUDE report names IXH 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 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 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?
My Breast Friend Breast Self-exam Pad is indicated as an aid for performing breast self-examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023390: MY Breast Friend, Breast Self-Exam Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023390
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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