510(k) · Cleared
ClearedMammopad Radiolucent Cushion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolucent, Inc. · IYX Camera, Scintillation (Gamma)
Cleared on Sep 13, 2006 as substantially equivalent to K003795 (Biolucent, Inc., 2001) after a 48-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Sep 13, 2006
- Review
- 48 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003795 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK003795 Biolucent Mammography CushionBiolucent, Inc. · 2001
- This deviceK062141 Mammopad Radiolucent CushionBiolucent, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK073262 BELLABeekley Corp. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK161920 Comfort CoverPrecision Dynamics Corporation · 2016
- Descendant · cites it directly · 0 of its ownK152038 MammoGRIPWomen'S Imaging Solutions Enterprises, LLC · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003795 | Biolucent Mammography Cushion | Biolucent, Inc. | 2001 | — |
| 0 (this device) | K062141 | Mammopad Radiolucent Cushion | Biolucent, Inc. | 2006 | — |
| +1 | K073262 | BELLA | Beekley Corp. | 2008 | 1 |
| +2 | K161920 | Comfort Cover | Precision Dynamics Corporation | 2016 | — |
| +1 | K152038 | MammoGRIP | Women'S Imaging Solutions Enterprises, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 IYX? 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 IYX device
- #1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K003795 | Biolucent Mammography CushionSummary page 1…R, 892.1 100 Device Classification: Class 11 (IZH) Class I (lYX) Predicate devices: MammoPad® (1K003795) Scintimammography Pad Set, PineStar Technology Scint… | 2001 |
| * | — | Scintimammography Pad Set, PineStar Technology Named without a submission number | |
| * | — | Scintimammography Pad, Cone Instruments Named without a submission number |
What descends from it? (3)
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?
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray or scintillation technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062141: Mammopad Radiolucent Cushion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062141
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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