510(k) · Cleared
ClearedAccess Breast Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Confirma, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Aug 24, 2005 as substantially equivalent to K000993 (Usa Instruments, Inc., 2000) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 24, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K003340 (2000). 4 ancestors in all, the oldest K000993 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003340 | Obc-149 Breast Array Coil | Mri Devices Corp. | 2000 | — |
| −1 | K013985 | Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXX | Machnet BV | 2002 | — |
| 0 (this device) | K052045 | Access Breast Coil | Confirma, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K000993 | Liberty 9000 Breast CoilSummary page 3…Model: Liberty 9000 Breast Coil Manufacturer: USA Instruments, Inc. 510 (k) Number: K000993 Model: Machnet Bilateral Open Breast Coil Manufacturer: Machnet BV… | 2000 |
| * | K013985 | Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXXSummary page 3…Model: Machnet Bilateral Open Breast Coil Manufacturer: Machnet BV 510 (k) Number: K013985 Model: Biopsy Breast Coil BBC-127 Manufacturer: MRI Devices Corpora… | 2002 |
| * | K041481 | Model BBC-127 Biopsy Breast CoilSummary page 3…Model: Biopsy Breast Coil BBC-127 Manufacturer: MRI Devices Corporation 510 (k) Number: K041481 All of these breast coils are designed as receive-only RF coils and intended for use in conjunction with… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 | — |
What is it indicated for?
The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052045: Access Breast Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052045
Report an extraction error
Are you the manufacturer?
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