510(k) · Cleared
ClearedAos Universal Connecting Guide Tube for High Dose Rate Afterloaders
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alpha-Omega Services, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Mar 10, 1997 as substantially equivalent to K881665 (Omnitron Intl., Inc., 1988) after a 91-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Mar 10, 1997
- Review
- 91 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881665 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK881665 Omnitron Remote Controlled Radionuclide ApplicatorOmnitron Intl., Inc. · 1988
- This deviceK964910 Aos Universal Connecting Guide Tube for High Dose Rate AfterloadersAlpha-Omega Services, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK062824 Aos Universal Conecting Guide TubeAlpha-Omega Services, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062824Aos Universal Conecting Guide TubeAlpha-Omega Services, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881665 | Omnitron Remote Controlled Radionuclide Applicator | Omnitron Intl., Inc. | 1988 | — |
| 0 (this device) | K964910 | Aos Universal Connecting Guide Tube for High Dose Rate Afterloaders | Alpha-Omega Services, Inc. | 1997 | — |
| +1 | K062824 | Aos Universal Conecting Guide Tube | Alpha-Omega Services, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K962913 | FDA’s K962913 is Synthes Sterile Drill Bits Our OCR of the scanned summary read K962913, FDA’s number for Synthes Sterile Drill Bits (Synthes (Usa)). Its FDA name has none of the distinctive words the summary uses for the device it names, “Varian Coupling Catheters”. Kept off the family tree. Summary page 2…ccepted clinical practice or institution guidelines. The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K962913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All… | 1996 |
| * | K881665 | Omnitron Remote Controlled Radionuclide ApplicatorSummary page 1…erformance Standards for Brachytherapy Applicators are in effect at this date. PREDICATED DEVICE Varian Coupling Catheters (K952913) and Omnitron International System (K881665). INDICATIONS To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devic… | 1988 |
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 |
|---|---|---|---|
| K062824 | Aos Universal Conecting Guide Tube | 2007 | 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?
- Its one ancestor has no recall.
- Of its descendants, K062824 (Alpha-Omega Services, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy.
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/K964910 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964910: Aos Universal Connecting Guide Tube for High Dose Rate Afterloaders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964910
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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