510(k) · Cleared

Cleared

AOS Marker Seeds (SMG0242-025)

K233626510(k) TraditionalCleared Jul 2, 2024232-day reviewClass II21 CFR 892.5700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Alpha-Omega Services, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Jul 2, 2024 as substantially equivalent to K062825 (Alpha-Omega Services, Inc., 2007) after a 232-day review. Its family tree reaches back 1 generation to 2007.

Decided: Jul 2, 2024
Review: 232 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K062825 (2007). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK062825 Aos Marker SeedsAlpha-Omega Services, Inc. · 2007
This deviceK233626 AOS Marker Seeds (SMG0242-025)Alpha-Omega Services, Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K062825	Aos Marker Seeds	Alpha-Omega Services, Inc.	2007	—
0 (this device)	K233626	AOS Marker Seeds (SMG0242-025)	Alpha-Omega Services, Inc.	2024	—

FIG. 1 — Lineage of K233626, 2007–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K062825	Aos Marker Seeds Summary page 4 …ber 892.5700 Product Code JAQ \| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K062825 AOS Marker Seeds JAQ Device Description Summary 21 CFR 807.92(a)(4) AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds use…	Alpha-Omega Services, Inc.	2007	—

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?

Its one ancestor has no recall.

How does its category compare?

All JAQ devices

JAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · JAQ

6in 2025

2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007high 252 (2018) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAQ

1in 2019

2007high 13 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAQ

3in 2025

2007high 43 (2013) · low 1 (2024)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?

AOS Marker Seeds are 24k gold 5mm x .8mm cylindric seeds used to provide reference positions around a proposed brachytherapy treatment site in adults.

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/K233626 · printed Nov 6, 2026

Cite this page

510(k) Report. “K233626: AOS Marker Seeds (SMG0242-025).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233626

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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