510(k) · Cleared
ClearedAos Interstitial Templates, Needles & Accessories
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 May 29, 2007 after a 251-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 29, 2007
- Review
- 251 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK062823 Aos Interstitial Templates, Needles & AccessoriesAlpha-Omega Services, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK233628 AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233628AOS Interstitial Templates, Needles, and AccessoriesAlpha-Omega Services, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062823 | Aos Interstitial Templates, Needles & Accessories | Alpha-Omega Services, Inc. | 2007 | — |
| +1 | K233628 | AOS Interstitial Templates, Needles, and Accessories | Alpha-Omega Services, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (8)
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 |
|---|---|---|---|
| * | — | AOS Prostate Template Named without a submission number | |
| * | — | Rectal Template Named without a submission number | |
| * | — | GYN Template Named without a submission number | |
| * | — | AOS Template Needle Named without a submission number | |
| * | — | AOS Template Tip Named without a submission number | |
| * | — | AOS Implant Tube Named without a submission number | |
| * | — | AOS Implant Needle Named without a submission number | |
| * | — | AOS Retaining Button Named without a submission number |
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 |
|---|---|---|---|
| K233628 | AOS Interstitial Templates, Needles, and Accessories | 2024 | 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?
- Of its descendants, K233628 (Alpha-Omega Services, Inc., 2024) 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. 2007, this device’s year, is highlighted.
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?
The purpose of AOS Interstitial Templates, Needles and Accessories is to provide and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062823: Aos Interstitial Templates, Needles & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062823
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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