510(k) · Cleared
ClearedBiolucent Mammography Cushion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolucent, Inc. · IZH System, X-Ray, Mammographic
Cleared on Feb 14, 2001 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 14, 2001
- Review
- 68 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK003795 Biolucent Mammography CushionBiolucent, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK062141 Mammopad Radiolucent CushionBiolucent, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK073262 BELLABeekley Corp. · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK161920 Comfort CoverPrecision Dynamics Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK152038 MammoGRIPWomen'S Imaging Solutions Enterprises, LLC · 2015
- Descendant · cites it directly · 0 of its ownK031574 Squeeze-Ease Mammography CushionS & S X-Ray Products, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K062141Mammopad Radiolucent CushionBiolucent, Inc. · 2006 · cites it directly3descendants
- K073262BELLABeekley Corp. · 2008 · 2 generations on1descendant
- K161920Comfort CoverPrecision Dynamics Corporation · 2016 · 3 generations on0descendants
- K152038MammoGRIPWomen'S Imaging Solutions Enterprises, LLC · 2015 · 2 generations on0descendants
- K031574Squeeze-Ease Mammography CushionS & S X-Ray Products, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003795 | Biolucent Mammography Cushion | Biolucent, Inc. | 2001 | — |
| +1 | K062141 | Mammopad Radiolucent Cushion | Biolucent, Inc. | 2006 | — |
| +2 | K073262 | BELLA | Beekley Corp. | 2008 | 1 |
| +3 | K161920 | Comfort Cover | Precision Dynamics Corporation | 2016 | — |
| +2 | K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | 2015 | — |
| +1 | K031574 | Squeeze-Ease Mammography Cushion | S & S X-Ray Products, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (5)
2 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?
- Of its descendants, K062141 (Biolucent, Inc., 2006) has gone furthest, with 3 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/K003795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003795: Biolucent Mammography Cushion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003795
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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