510(k) · Cleared
ClearedC-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. Dba Civco Medical Solutions and Civco · IYE Accelerator, Linear, Medical
Cleared on May 20, 2021 as substantially equivalent to K180021 (Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap, 2018) after a 48-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- May 20, 2021
- Review
- 48 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973842 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK973842 Carbon Fiber Conformal Couch TopMedtec, Inc. · 1997 · Recalled
- 1 generation backK180021 Proton Positioing and Immobilization DevicesMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap · 2018
- This deviceK211001 C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerMedtec, Inc. Dba Civco Medical Solutions and Civco · 2021
- Descendant · cites it directly · 0 of its ownK213439 FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV · 2022
Most influential descendants
Showing 1 of 1 · See all- K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTMMacromedics BV · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973842 | Carbon Fiber Conformal Couch Top | Medtec, Inc. | 1997 | 7 |
| −1 | K180021 | Proton Positioing and Immobilization Devices | Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap | 2018 | — |
| 0 (this device) | K211001 | C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner | Medtec, Inc. Dba Civco Medical Solutions and Civco | 2021 | — |
| +1 | K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | Macromedics BV | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 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? (1)
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 |
|---|---|---|---|
| * | K180021 | Proton Positioing and Immobilization DevicesSummary page 4…m Positioner are substantially equivalent to the following predicate device: Predicate Device Manufacturer K180021: Proton Positioning and Immobilization Devices CIVCO Radiotherapy (Breast Devices) The purpose of this 510(k) i… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213439 | FlexBoardTM, EagleBoardTM, BreastBoard SXTM | 2022 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 20.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K213439 (Macromedics BV, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180021.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211001: C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211001
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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