510(k) · Cleared
ClearedAware Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aac Consulting Group, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 20, 1999 as substantially equivalent to K973450 (Inventive Products, Inc., 1997) after an 83-day review. Its family tree reaches back 2 generations to 1995. 22 later devices descend from it.
- Decided
- Jul 20, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955249 (1995). 22 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 1 generation backK973450 Sensor PadInventive Products, Inc. · 1997
- This deviceK991469 Aware PadAac Consulting Group, Inc. · 1999
- Descendant · cites it directly · 21 of its ownK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- Descendant · 2 generations on · 17 of its ownK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- Descendant · 3 generations on · 16 of its ownK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 11 of its ownK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
- Descendant · 5 generations on · 10 of its ownK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K023390MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002 · cites it directly21descendants
- K050602AltaireHitachi Medical Systems America, Inc. · 2005 · 2 generations on17descendants
- K052172HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · 3 generations on16descendants
- K083533Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · 4 generations on11descendants
- K113145Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · 5 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −1 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| 0 (this device) | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| +1 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| +2 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| +3 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| +4 | K083533 | Echelon C Mri System | Hitachi Medical Systems America, Inc. | 2009 | 2 |
| +5 | K113145 | Echelon Oval Mri System | Hitachi Medical Systems America, Inc. | 2012 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K973450 | Sensor PadSummary page 1…erformance or voluntary standards are applicable. SUBSTANTIAL EQUIVALENCE: The Aware ™ pad is substantially equivalent to a currently marketed device, the Sensor Pad® (K973450). INDICATIONS FOR USE: The Aware™ Pad is indicated as an aid for performing breast self-examination. TECHNOLOGICAL CHARACTERIS… | 1997 |
What descends from it? (22)
See all 222 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 4 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K023390 (Mbf Sales, LLC, 2002) has gone furthest, with 21 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?
The Aware™ Pad is indicated as an aid for performing breast self-examination.
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/K991469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991469: Aware Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991469
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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