510(k) · Cleared

Cleared

Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM

K140803510(k) TraditionalCleared Jun 26, 201487-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 B.V. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Jun 26, 2014 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 1986.

Decided: Jun 26, 2014
Review: 87 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K864210 (1986). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
3 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
2 generations backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
1 generation backK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
This deviceK140803 Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM…Nucletron B.V. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K864210	Microselectron-HDR (High Dose Rate)	Nucletron-Oldelft Corp.	1986	—
−3	K953946	Microselectron-HDR Version 2	Nucletron-Oldelft Corp.	1996	—
−2	K020015	Implant Guidance System Applicator Set	Nucletron Corp.	2002	—
−1	K032372	Nucletron Comfort Catheter System, Model 189.007	Nucletron Corporation	2003	—
0 (this device)	K140803	Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM	Nucletron B.V.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K140803, 1986–2014Source: 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? (2)

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
*	K953946	Microselectron-HDR Version 2 Summary page 2 …redicate devices are handled manually; Luneray can also be handled with laparoscopic tools. Luneray is delivered sterile. The predicate devices are delivered unsterile (K953946) or some components are delivered sterile (K032372). The differences do not affect the similarity in principal technology, funct…	Nucletron-Oldelft Corp.	1996	—
*	K032372	Nucletron Comfort Catheter System, Model 189.007 Summary page 2 …also be handled with laparoscopic tools. Luneray is delivered sterile. The predicate devices are delivered unsterile (K953946) or some components are delivered sterile (K032372). The differences do not affect the similarity in principal technology, function and operational characteristics of the devices.…	Nucletron Corporation	2003	—

Also cleared against K953946: 27 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 28 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
None of the 5 ancestors has a recall.
27 other devices also cite its predicate K953946.

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. 2014, 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?

Luneray is intended for interstitial brachytherapy of soft tissue that allows the Insertion of this flexible applicator, e.g.:

Abdominal structures / organs (e.g. urinary bladder)

Head and neck (e.g. ear, lip, nose, tongue, oral mucosa)

Skin (e.g. keloids)

Soft tissue sarcoma

Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140803 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140803: Luneray;Catheter 6F 50CM, Needle 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140803

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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