510(k) · Cleared
ClearedLumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM, Lumencare Azure Set 5F, 140 CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron B.V. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Feb 21, 2014 after a 161-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 21, 2014
- Review
- 161 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK132874 Lumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM…Nucletron B.V. · 2014
- Descendant · cites it directly · 0 of its ownK262383 LumenCare AzureNucletron B.V. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262383LumenCare AzureNucletron B.V. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132874 | Lumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM, Lumencare Azure… | Nucletron B.V. | 2014 | — |
| +1 | K262383 | LumenCare Azure | Nucletron B.V. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | — | Lumencath Applicator Set Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262383 | LumenCare Azure | 2026 | 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?
- Of its descendants, K262383 (Nucletron B.V., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JAQ devicesJAQ 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 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 LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct.
The LumenCare Azure is designed to fit in the working channel of an endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132874: Lumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM, Lumencare Azure Set 5F, 140 CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132874
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