510(k) · Cleared

Cleared

Aos Universal Conecting Guide Tube

K062824510(k) TraditionalCleared Jul 3, 2007286-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 3, 2007 as substantially equivalent to K964910 (Alpha-Omega Services, Inc., 1997) after a 286-day review. Its family tree reaches back 2 generations to 1988.

Decided: Jul 3, 2007
Review: 286 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K881665 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK881665 Omnitron Remote Controlled Radionuclide ApplicatorOmnitron Intl., Inc. · 1988
1 generation backK964910 Aos Universal Connecting Guide Tube for High Dose Rate AfterloadersAlpha-Omega Services, Inc. · 1997
This deviceK062824 Aos Universal Conecting Guide TubeAlpha-Omega Services, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K881665	Omnitron Remote Controlled Radionuclide Applicator	Omnitron Intl., Inc.	1988	—
−1	K964910	Aos Universal Connecting Guide Tube for High Dose Rate Afterloaders	Alpha-Omega Services, Inc.	1997	—
0 (this device)	K062824	Aos Universal Conecting Guide Tube	Alpha-Omega Services, Inc.	2007	—

FIG. 1 — Lineage of K062824, 1988–2007Source: 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
*	K964910	Aos Universal Connecting Guide Tube for High Dose Rate Afterloaders Summary page 1 …OMMON/USUAL NAME Afterloader Coupling Catheter CLASSIFICATION NAME 21 CFR 892.5700, Product Code: JAQ, Class II PREDICATED DEVICES AOS Universal Connecting Guide Tube, K964910 DESCRIPTION Alpha-Omega Services (AOS) Universal Connecting Guide Tube is used to connect any Alpha-Omega applicator accessory w…	Alpha-Omega Services, Inc.	1997	—

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 19 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
None of the 2 ancestors has a 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. 2007, 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?

The purpose of the AGS Universal Connecting Guide Tube is to provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply radionuclide source into the body or to the surface of the body for radiation therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062824 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062824: Aos Universal Conecting Guide Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062824

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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