510(k) · Cleared
ClearedAktina Medical Physics Corporation Active Breathing Coordinator (Abc)
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 Jan 4, 2001 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jan 4, 2001
- Review
- 72 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK003330 Aktina Medical Physics Corporation Active Breathing Coordinator (Abc)Aktina Medical Physics Corp. · 2001
- Descendant · cites it directly · 1 of its ownK131313 Active Breathing CoordinatorAktina Medical Corp. · 2013
- Descendant · cites it directly · 1 of its ownK092845 RespisensNomics · 2010
- Descendant · cites it directly · 1 of its ownK092479 SDX-Spirodynr'x Radiotherapy Breathing ControlDyn'R · 2010
- Descendant · 2 generations on · 0 of its ownK151097 Active Breathing CoordinatorAktina Medical Corporation · 2015
- Descendant · 2 generations on · 0 of its ownK121845 SDX SystemDyn'R Sas · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K131313Active Breathing CoordinatorAktina Medical Corp. · 2013 · cites it directly1descendant
- K092845RespisensNomics · 2010 · cites it directly1descendant
- K092479SDX-Spirodynr'x Radiotherapy Breathing ControlDyn'R · 2010 · cites it directly1descendant
- K151097Active Breathing CoordinatorAktina Medical Corporation · 2015 · 2 generations on0descendants
- K121845SDX SystemDyn'R Sas · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003330 | Aktina Medical Physics Corporation Active Breathing Coordinator (Abc) | Aktina Medical Physics Corp. | 2001 | — |
| +1 | K131313 | Active Breathing Coordinator | Aktina Medical Corp. | 2013 | — |
| +1 | K092845 | Respisens | Nomics | 2010 | — |
| +1 | K092479 | SDX-Spirodynr'x Radiotherapy Breathing Control | Dyn'R | 2010 | — |
| +2 | K151097 | Active Breathing Coordinator | Aktina Medical Corporation | 2015 | — |
| +2 | K121845 | SDX System | Dyn'R Sas | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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, K131313 (Aktina Medical Corp., 2013) has gone furthest, with 1 descendant 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/K003330 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003330: Aktina Medical Physics Corporation Active Breathing Coordinator (Abc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003330
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026