510(k) · Cleared
Recalled · Class II · 2019Flexitron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isodose Control B.V. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 13, 2007 as substantially equivalent to K953946 (Nucletron-Oldelft Corp., 1996) and 1 other predicate after a 44-day review. Its family tree reaches back 3 generations to 1991. It has been recalled once.
- Decided
- Apr 13, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912555 (1991). 6 ancestors in all, the oldest K864210 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 2 generations backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- 1 generation backK031524 Gammamed Plus 3/24 HDR Remote AfterloaderVarian Medical Systems, Inc. · 2003 · Recalled
- This deviceK070574 FlexitronIsodose Control B.V. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −2 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| −1 | K031524 | Gammamed Plus 3/24 HDR Remote Afterloader | Varian Medical Systems, Inc. | 2003 | 1 |
| 0 (this device) | K070574 | Flexitron | Isodose Control B.V. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 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? (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 | Decided |
|---|---|---|---|
| * | K953946 | Microselectron-HDR Version 2Summary page 1…Manufacturer 510(k # ImicroSelectron-HDR Version 2 INucletron byv K953946 GammaMed Plus 3/24 High Dose Rate (HDR) Varian Medical Systems Inc K031524 Remote Afterloader company Con… | 1996 |
| * | K031524 | Gammamed Plus 3/24 HDR Remote AfterloaderSummary page 1…ctron-HDR Version 2 INucletron byv K953946 GammaMed Plus 3/24 High Dose Rate (HDR) Varian Medical Systems Inc K031524 Remote Afterloader company Confidential Section 5: 510(k) Summary… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2019 | Class II | Z-0772-2020 | Process control | A component failure may lead to treatment interruption or incorrect source positioning. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 27 other devices also cite its predicate K953946.
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. 2007, 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 Flexitron Remotely Controlled Brachytherapy Afterloading System is intended to enable an operator to apply by remote control a radionuclide source (Flexisource) into the body or to the surface of the body for radiation therapy.
Flexitron is intended to be used in combination with applicators which makes it suitable for intracavitary, interstitial, intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy treatment.
Flexitron is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and authorized medical professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070574: Flexitron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070574
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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