510(k) · Cleared
ClearedSensor Pad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inventive Products, Inc. · IZH System, X-Ray, Mammographic
Cleared on Dec 22, 1995 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 24 later devices descend from it.
- Decided
- Dec 22, 1995
- Review
- 37 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 1 citing it directly.
- This deviceK955249 Sensor PadInventive Products, Inc. · 1995
- Descendant · cites it directly · 23 of its ownK973450 Sensor PadInventive Products, Inc. · 1997
- Descendant · 2 generations on · 22 of its ownK991469 Aware PadAac Consulting Group, Inc. · 1999
- Descendant · 2 generations on · 21 of its ownK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- Descendant · 3 generations on · 17 of its ownK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- Descendant · 4 generations on · 16 of its ownK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K973450Sensor PadInventive Products, Inc. · 1997 · cites it directly23descendants
- K991469Aware PadAac Consulting Group, Inc. · 1999 · 2 generations on22descendants
- K023390MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002 · 2 generations on21descendants
- K050602AltaireHitachi Medical Systems America, Inc. · 2005 · 3 generations on17descendants
- K052172HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| +1 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| +2 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| +2 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| +3 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| +4 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973450 | Sensor Pad | 1997 | 23 |
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?
- Of its descendants, K973450 (Inventive Products, Inc., 1997) has gone furthest, with 23 descendants of its own.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K955249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955249: Sensor Pad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955249
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026