510(k) · Cleared
ClearedAktina Medical Physics Radiation Therapy Wedges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aktina Medical Physics Corp. · IYE Accelerator, Linear, Medical
Cleared on Mar 5, 2002 as substantially equivalent to K862339 (Siemens Medical Laboratories, Inc., 1986) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Mar 5, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K832503 (1983). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK832503 Clinac 1800Varian Assoc., Inc. · 1983
- This deviceK014081 Aktina Medical Physics Radiation Therapy WedgesAktina Medical Physics Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832503 | Clinac 1800 | Varian Assoc., Inc. | 1983 | — |
| 0 (this device) | K014081 | Aktina Medical Physics Radiation Therapy Wedges | Aktina Medical Physics Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 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? (2)
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 |
|---|---|---|---|
| * | K862339 | Mevatron KD-2Summary page 1…e 9 W Congers, New York, 10920 Phone: 914-268-0101 FAX: 914-268-1700 Registration Number: 2436865 Name of Predicate Devices Mevatron KD-2, Siemens Medical Labs, Inc., K862339 Clinac 1800, Varian Associates, Inc., K832503 1 Any statement made in conjunction with this submission regarding substantial eq… | 1986 |
| * | K832503 | Clinac 1800Summary page 1…0101 FAX: 914-268-1700 Registration Number: 2436865 Name of Predicate Devices Mevatron KD-2, Siemens Medical Labs, Inc., K862339 Clinac 1800, Varian Associates, Inc., K832503 1 Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to… | 1983 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K862339.
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?
In radiation therapy, it is often desirable to modify the intensity or penetrating depth of a treatment beam so as to minimize radiation exposure to normal tissue. Many devices have and are used for this function including but not limited to partial beam blocks, tissue compensating filters, the most commonly, the wedge. This physical device is constructed of high-density materials that when machined into a wedge shaped block, differentially attenuate the…
Read the full statement (133 words)
In radiation therapy, it is often desirable to modify the intensity or penetrating depth of a treatment beam so as to minimize radiation exposure to normal tissue. Many devices have and are used for this function including but not limited to partial beam blocks, tissue compensating filters, the most commonly, the wedge. This physical device is constructed of high-density materials that when machined into a wedge shaped block, differentially attenuate the transmitted radiation beam. The resulting radiation beam that is transmitted through the wedge will have a sloped intensity at the patient surface as compared to an un-attenuated beam, which is uniform and consistent in intensity across the beam at the patient's surface. These wedges are designed for use only as a beam-modifying agent with photon beams in Radiation Therapy external beam treatments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014081 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014081: Aktina Medical Physics Radiation Therapy Wedges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014081
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026