510(k) · Cleared
ClearedSensatouch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aluna Management Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 12, 2004 as substantially equivalent to K973450 (Inventive Products, Inc., 1997) and 2 other predicates after an 84-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Nov 12, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K955249 (1995). 1 later device descends from it, 1 citing it directly.
- 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 deviceK042250 SensatouchAluna Management Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK071787 Bemitt, Model 0001Dja Distributors, LLC · 2007
Most influential descendants
Showing 1 of 1 · See all- K071787Bemitt, Model 0001Dja Distributors, LLC · 2007 · cites it directly0descendants
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) | K042250 | Sensatouch | Aluna Management Co., Ltd. | 2004 | — |
| +1 | K071787 | Bemitt, Model 0001 | Dja Distributors, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…able. 3. Substantial Equivalence The SensaTouchTM - Breast Self-Exam Glove is substantially equivalent to the currently marketed OTC devices, Sensor Pad (K973450), My Breast Friend (K023390), and Aware Pad (K991469). 4. Indications for Use The SensaTouchTM - Breast Self-Exam… | 1997 |
| * | K023390 | MY Breast Friend, Breast Self-Exam PadSummary page 1…ivalence The SensaTouchTM - Breast Self-Exam Glove is substantially equivalent to the currently marketed OTC devices, Sensor Pad (K973450), My Breast Friend (K023390), and Aware Pad (K991469). 4. Indications for Use The SensaTouchTM - Breast Self-Exam Glove is indicated as an ai… | 2002 |
| * | K991469 | Aware PadSummary page 1…- Breast Self-Exam Glove is substantially equivalent to the currently marketed OTC devices, Sensor Pad (K973450), My Breast Friend (K023390), and Aware Pad (K991469). 4. Indications for Use The SensaTouchTM - Breast Self-Exam Glove is indicated as an aid for performing breast self-… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071787 | Bemitt, Model 0001 | 2007 | 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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K071787 (Dja Distributors, LLC, 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K973450.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
SensaTouchTM is indicated as an aid for performing breast self-examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042250: Sensatouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042250
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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