510(k) · Cleared

Cleared

Applicators for Afterloading Brachytherapy

K082530510(k) AbbreviatedCleared Oct 30, 200858-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

Isodose Control B.V. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Oct 30, 2008 as substantially equivalent to K983341 (Nucletron Corp., 1999) and 7 other predicates after a 58-day review. Its family tree reaches back 5 generations to 1986.

Decided: Oct 30, 2008
Review: 58 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 8

Its longest line of descent runs back 5 generations to K864210 (1986). 17 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

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 backK011657 HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2001 · Recalled
2 generations backK030110 CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2003 · Recalled
1 generation backK063382 HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc. · 2006
This deviceK082530 Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008

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	K011657	HDR Tandem/Ring Applicator with Rectal Retractor	Mick Radio-Nuclear Instruments, Inc.	2001	2
−2	K030110	CT HDR Tandem/Ring Applicator with Rectal Retractor	Mick Radio-Nuclear Instruments, Inc.	2003	1
−1	K063382	HDR CT Compatible Split Ring Applicator	Mick Radio-Nuclear Instruments, Inc.	2006	—
0 (this device)	K082530	Applicators for Afterloading Brachytherapy	Isodose Control B.V.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1993	1	0
1995	1	0
1996	1	0
1998	1	0
1999	2	0
2000	1	0
2006	1	0
2007	2	0

FIG. 1 — Lineage of K082530, 1986–2008Source: 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? (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	Applicant	Decided	Recalls
*	K983341	Standard CT/MR Applicator Set,Ring CT/MR Applicator Set, Vaginal CT/MR Applicator Set… Summary page 2 …Manufacturer 510(k) # Standard CT/MR Applicator set, Ring CT/MR Nucletron corp K983341 applicator HDRCT compatible Split Ring Applicator Mick Radio-nuclear K063382…	Nucletron Corp.	1999	—
*	K063382	HDR CT Compatible Split Ring Applicator Summary page 2 …ucletron corp K983341 applicator HDRCT compatible Split Ring Applicator Mick Radio-nuclear K063382 Instruments, inc HDR Tandem /Ring applicator with rectal retractor…	Mick Radio-Nuclear Instruments, Inc.	2006	—
*	K011657	HDR Tandem/Ring Applicator with Rectal Retractor Summary page 2 …Instruments, inc HDR Tandem /Ring applicator with rectal retractor Mick Radio-nuclear K011657 Instruments, inc 5.3.2. Trocar Needle sets Device…	Mick Radio-Nuclear Instruments, Inc.	2001	2
*	K060349	Proguide Needle Set Summary page 2 …Manufacturer 510(k) # Proguide Needle set Nucletron Corp K060349 Interstitial Needles Varian Medical Systems, Inc K073133 5.3.3. Martine…	Nucletron Corporation	2006	—
*	K073133	Interstitial Needles Summary page 2 …Nucletron Corp K060349 Interstitial Needles Varian Medical Systems, Inc K073133 5.3.3. Martinez Prostate template Device Manufacturer…	Varian Medical Systems, Inc.	2007	—
*	K003270	Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067 Summary page 2 …Manufacturer 510(k) # Prostate Stepper Template Set Nucletron Corp. K003270 Cet Prostate Applicator Set Nucletron Corp K990990 5.3.4. Bonvoisi…	Nucletron Corp.	2000	—
*	K990990	Cet Prostate Applicator Set, Part Number 089.066 Summary page 2 …Nucletron Corp. K003270 Cet Prostate Applicator Set Nucletron Corp K990990 5.3.4. Bonvoisin Gerard Esophageal Applicator Set Varian Esophagus Bougie Applicator Varian Medical Systems, Inc…	Nucletron Corp.	1999	—
*	K063815	Varian Esophagus Bougie Applicator Summary page 2 …K990990 5.3.4. Bonvoisin Gerard Esophageal Applicator Set Varian Esophagus Bougie Applicator Varian Medical Systems, Inc K063815 ------------------------------------------------------------------ 5.4. Description of the Device The following described medic…	Varian Medical Systems	2007	—

Also cleared against K983341: 4 other devices →

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 22 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
5 of the 17 ancestors have a recall of any class.
4 other devices also cite its predicate K983341.

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. 2008, 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?

Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Cervix Ring Applicator The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation duration per treatment application is 28 days. Trocar Needle Sets The intended use is…

Read the full statement (159 words)

Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue.

Cervix Ring Applicator

The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation duration per treatment application is 28 days.

Trocar Needle Sets

The intended use is interstitial HDRIPDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days.

Martinez Prostate Template Set

The Martinez Prostate Template Set is for assisting interstitial HDRPPDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days.

Bonvoisin Gerard Esophaqeal Applicator Set

The Bonvoisin Gerard Esopheagel Applicator is intended for brachytherapy treatment of the esophagus, to be used only by trained physicians. The maximum implementation duration per treatment application is 24 hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082530 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082530: Applicators for Afterloading Brachytherapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082530

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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