510(k) · Cleared

Cleared

Nucletron Comfort Catheter System, Model 189.007

K032372510(k) TraditionalCleared Aug 15, 200314-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

Nucletron Corporation · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Aug 15, 2003 as substantially equivalent to K020015 (Nucletron Corp., 2002) after a 14-day review. Its family tree reaches back 3 generations to 1986. 19 later devices descend from it.

Decided: Aug 15, 2003
Review: 14 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K864210 (1986). 4 ancestors in all. 19 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
1 generation backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
This deviceK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
Descendant · cites it directly · 17 of its ownK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
Descendant · cites it directly · 13 of its ownK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
Descendant · 2 generations on · 12 of its ownK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
Descendant · cites it directly · 11 of its ownK081677 Savi Applicator KitCianna Medical, Inc. · 2008
Descendant · 2 generations on · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2006high 3 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 19 · See all

K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006 · cites it directly17descendants
K070659Biolucent Applicator KitBiolucent, Inc. · 2007 · cites it directly13descendants
K080565Modification to: Savi Applicator KitCianna Medical, Inc. · 2008 · 2 generations on12descendants
K081677Savi Applicator KitCianna Medical, Inc. · 2008 · cites it directly11descendants
K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K864210	Microselectron-HDR (High Dose Rate)	Nucletron-Oldelft Corp.	1986	—
−2	K953946	Microselectron-HDR Version 2	Nucletron-Oldelft Corp.	1996	—
−1	K020015	Implant Guidance System Applicator Set	Nucletron Corp.	2002	—
0 (this device)	K032372	Nucletron Comfort Catheter System, Model 189.007	Nucletron Corporation	2003	—
+1	K061241	Biolucent Applicator, Model Rta-XX	Biolucent, Inc.	2006	—
+1	K070659	Biolucent Applicator Kit	Biolucent, Inc.	2007	—
+2	K080565	Modification to: Savi Applicator Kit	Cianna Medical, Inc.	2008	—
+1	K081677	Savi Applicator Kit	Cianna Medical, Inc.	2008	—
+2	K091378	Mammosite II Radiation Therapy System	Hologic, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	2	0
2009	3	0
2012	2	0
2014	3	0
2016	2	0
2017	1	0
2018	1	0
2019	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K032372, 1986–2025Source: 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

Get a 510(k) Report

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
*	K020015	Implant Guidance System Applicator Set	Nucletron Corp.	2002	—

What descends from it? (19)

See all 19

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061241	Biolucent Applicator, Model Rta-XX	Biolucent, Inc.	2006	17
K070659	Biolucent Applicator Kit	Biolucent, Inc.	2007	13
K081677	Savi Applicator Kit	Cianna Medical, Inc.	2008	11
K140803	Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM	Nucletron B.V.	2014	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?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K061241 (Biolucent, Inc., 2006) has gone furthest, with 17 descendants of its own.

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.

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?

Comfort Catheter System is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032372 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032372: Nucletron Comfort Catheter System, Model 189.007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032372

Report an extraction error

Are you the manufacturer?

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