510(k) · Cleared
ClearedAos Orion IR-192 Source Cable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha-Omega Services, Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Jun 2, 2011 as substantially equivalent to K092804 (Nucletron Corp., 2009) and 1 other predicate after a 247-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Jun 2, 2011
- Review
- 247 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K864210 (1986). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 4 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 3 generations backK041933 Microselectron PDRNucletron Corp. · 2004
- 2 generations backK061354 Microselectron V3, Model 106.990Nucletron Corporation · 2006
- 1 generation backK092804 Microselectron HDR V2, Model 105.999Nucletron Corp. · 2009
- This deviceK102811 Aos Orion IR-192 Source CableAlpha-Omega Services, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −4 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −3 | K041933 | Microselectron PDR | Nucletron Corp. | 2004 | — |
| −2 | K061354 | Microselectron V3, Model 106.990 | Nucletron Corporation | 2006 | — |
| −1 | K092804 | Microselectron HDR V2, Model 105.999 | Nucletron Corp. | 2009 | — |
| 0 (this device) | K102811 | Aos Orion IR-192 Source Cable | Alpha-Omega Services, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 KXK? 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 KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 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 |
|---|---|---|---|
| * | K092804 | Microselectron HDR V2, Model 105.999Summary page 1…2022694, 3003660614 Special Controls None Substantial Equivalence: K092804 MicroSelectron HDR Version 2 K061354 MicroSelectron V3 2.… | 2009 |
| * | K061354 | Microselectron V3, Model 106.990Summary page 1…stantial Equivalence: K092804 MicroSelectron HDR Version 2 K061354 MicroSelectron V3 2. Device Description The AOS Orion lr-192 Source Cable (Model No. C500012-192) isa nominal 12 Curie Ir… | 2006 |
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, 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 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AOS Orion Ir-192 Source Cable is a sealed radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. This device is the replaceable Ir-192 source for the Nucletron Corp. MicroSelectron HDR V2 and V3 Afterloaders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102811: Aos Orion IR-192 Source Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102811
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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