510(k) · Cleared
ClearedLiberty 9000 Breast Coil with Disposable Biopsy Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Jul 17, 2000 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Jul 17, 2000
- Review
- 56 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK001582 Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2000
- Descendant · cites it directly · 9 of its ownK041695 Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 8 of its ownK052585 3T HD Breast ArrayUsa Instruments, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 3 of its ownK173377 3.0T 16ch Breast CoilNeocoil, LLC · 2017
- Descendant · 4 generations on · 2 of its ownK182958 1.5T 16ch Breast CoilNeocoil, LLC · 2018
- Descendant · 3 generations on · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K041695Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004 · cites it directly9descendants
- K0525853T HD Breast ArrayUsa Instruments, Inc. · 2005 · 2 generations on8descendants
- K1733773.0T 16ch Breast CoilNeocoil, LLC · 2017 · 3 generations on3descendants
- K1829581.5T 16ch Breast CoilNeocoil, LLC · 2018 · 4 generations on2descendants
- K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001582 | Liberty 9000 Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2000 | — |
| +1 | K041695 | Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2004 | 5 |
| +2 | K052585 | 3T HD Breast Array | Usa Instruments, Inc. | 2005 | 5 |
| +3 | K173377 | 3.0T 16ch Breast Coil | Neocoil, LLC | 2017 | — |
| +4 | K182958 | 1.5T 16ch Breast Coil | Neocoil, LLC | 2018 | — |
| +3 | K061715 | Mrgfus General Purpose and Breast Coil | Insightec Txsonics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (13)
See all 132 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, K041695 (Usa Instruments, Inc., 2004) has gone furthest, with 9 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
https://510kreport.com/device/K001582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001582: Liberty 9000 Breast Coil with Disposable Biopsy Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001582
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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