510(k) · Cleared
ClearedCarbon Fiber Breast Board
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. · IYE Accelerator, Linear, Medical
Cleared on Mar 10, 1998 after an 84-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it.
- Decided
- Mar 10, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK974703 Carbon Fiber Breast BoardMedtec, Inc. · 1998
- Descendant · cites it directly · 18 of its ownK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
- Descendant · cites it directly · 17 of its ownK060737 Sinmed Positioning DevicesSinmed BV · 2006
- Descendant · 2 generations on · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- Descendant · 3 generations on · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- Descendant · 2 generations on · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K030051Versaboard, Model 7040Bionix Development Corp. · 2003 · cites it directly18descendants
- K060737Sinmed Positioning DevicesSinmed BV · 2006 · cites it directly17descendants
- K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · 2 generations on14descendants
- K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 3 generations on13descendants
- K142420Patient Positioning DevicesMacromedics BV · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974703 | Carbon Fiber Breast Board | Medtec, Inc. | 1998 | — |
| +1 | K030051 | Versaboard, Model 7040 | Bionix Development Corp. | 2003 | — |
| +1 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| +2 | K093738 | Mri Patient Positioning Devices | Medtec, Inc. | 2010 | — |
| +3 | K111340 | Head and Neck Immobilization System, Body Immobilization System | Medtec, Inc. | 2011 | — |
| +2 | K142420 | Patient Positioning Devices | Macromedics BV | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (19)
See all 192 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, K030051 (Bionix Development Corp., 2003) has gone furthest, with 18 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The intended use of this device is to The MED-TEC, INC. Carbon Fiber Breast Board operates in the same manner as ordinary breast boards. or The intended use of the MED-TEC, INC. Carbon Fiber Breast Board is to support and aid in positioning a patient during radiologic and other medical procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974703 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974703: Carbon Fiber Breast Board.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974703
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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