510(k) · Cleared
Recalled · Class II · 2012BELLA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beekley Corp. · IZH System, X-Ray, Mammographic
Cleared on Mar 26, 2008 as substantially equivalent to K062141 (Biolucent, Inc., 2006) after a 127-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 26, 2008
- Review
- 127 days
- Class
- Class II
- Product code
- IZH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003795 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003795 Biolucent Mammography CushionBiolucent, Inc. · 2001
- 1 generation backK062141 Mammopad Radiolucent CushionBiolucent, Inc. · 2006
- This deviceK073262 BELLABeekley Corp. · 2008
- Descendant · cites it directly · 0 of its ownK161920 Comfort CoverPrecision Dynamics Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K161920Comfort CoverPrecision Dynamics Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003795 | Biolucent Mammography Cushion | Biolucent, Inc. | 2001 | — |
| −1 | K062141 | Mammopad Radiolucent Cushion | Biolucent, Inc. | 2006 | — |
| 0 (this device) | K073262 | BELLA | Beekley Corp. | 2008 | — |
| +1 | K161920 | Comfort Cover | Precision Dynamics Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 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 |
|---|---|---|---|
| * | K062141 | Mammopad Radiolucent CushionSummary page 2…mage quality. Comparison of device (Bella) to predicate device (MammoPad) Bella MammoPad K062141 Intended use A self adhering fabric sheet to be A self adhering foam pad to be… | 2006 |
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 |
|---|---|---|---|
| K161920 | Comfort Cover | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2012 | Class II | Z-2080-2012 | Nonconforming Material/Component | Imaging artifact can occur on mammogram result |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K161920 (Precision Dynamics Corporation, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062141.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 intended use of the product is to remove the cold from the bucky by placing this
sheet between the patient's breast and the imaging receptor plate allowing the patient to
feel more comfortable and less cold without interfering with image quality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073262: BELLA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073262
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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