510(k) · Cleared
Cleared“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braxx Biotech Co., Ltd. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Nov 19, 2024 as substantially equivalent to K183332 (Braxx Biotech Co., Ltd., 2019) after a 53-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Nov 19, 2024
- Review
- 53 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K183332 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK183332 “BRAXX” Esophageal Brachytherapy ApplicatorBraxx Biotech Co., Ltd. · 2019
- This deviceK243045 “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001…Braxx Biotech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K183332 | “BRAXX” Esophageal Brachytherapy Applicator | Braxx Biotech Co., Ltd. | 2019 | — |
| 0 (this device) | K243045 | “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) | Braxx Biotech Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K183332 | “BRAXX” Esophageal Brachytherapy ApplicatorSummary page 5…Class II Classification Panel Remote controlled radionuclide applicator syst 3 Predicate Device 510(k) number: K183332 Proprietary name: “BRAXX” Esophageal Brachytherapy Applicator Model Name BKMI2001… | 2019 |
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?
- Its one ancestor has no recall.
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. 2024, 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 Esophageal Brachytherapy Applicator is intended for use with commercially available
afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to
the esophagus. This device is sterile, disposable and single-use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243045: “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243045
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