510(k) · Cleared
ClearedMed-Tec, Inc. Breast Board, MT-200
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 Jul 18, 1994 after a 251-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jul 18, 1994
- Review
- 251 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK935412 Med-Tec, Inc. Breast Board, MT-200Medtec, Inc. · 1994
- Descendant · cites it directly · 9 of its ownK040773 Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004
- Descendant · 2 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- Descendant · 3 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- Descendant · 4 generations on · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK132124 Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 2013 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K040773Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004 · cites it directly9descendants
- K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 2 generations on5descendants
- K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 3 generations on3descendants
- K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · 4 generations on1descendant
- K132124Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935412 | Med-Tec, Inc. Breast Board, MT-200 | Medtec, Inc. | 1994 | — |
| +1 | K040773 | Pelvis Bellyboard Plus Patient Positioning System | Bionix Development Corp. | 2004 | — |
| +2 | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
| +3 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body… | Medtec, Inc. D/B/A Civco Medical Solutions | 2016 | — |
| +4 | K210894 | Siddharth-II; Impact | Panacea Medical Technologies Pvt., Ltd. | 2021 | — |
| +2 | K132124 | Klarity Vacuum Bag, Klarity Mold Cushion | Klarity Medical Products, LLC | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 122 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, K040773 (Bionix Development Corp., 2004) has gone furthest, with 9 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 | — |
https://510kreport.com/device/K935412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935412: Med-Tec, Inc. Breast Board, MT-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935412
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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