510(k) · Cleared
ClearedASSISTO Universal Applicator Clamping Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geomed Medizin-Technik GmbH & Co. KG · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jul 10, 2020 as substantially equivalent to K170203 (Kobold, LLC, 2017) after a 58-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jul 10, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003270 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK003270 Prostate Stepper Template Set, Model Part Number…Nucletron Corp. · 2000
- 2 generations backK091230 HDR Prostate Template and AccessoriesPhoton Technologies Corporation · 2009
- 1 generation backK170203 System, Applicator, Radionuclide, Remote ControlledKobold, LLC · 2017
- This deviceK201279 ASSISTO Universal Applicator Clamping DeviceGeomed Medizin-Technik GmbH & Co. KG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067 | Nucletron Corp. | 2000 | — |
| −2 | K091230 | HDR Prostate Template and Accessories | Photon Technologies Corporation | 2009 | — |
| −1 | K170203 | System, Applicator, Radionuclide, Remote Controlled | Kobold, LLC | 2017 | — |
| 0 (this device) | K201279 | ASSISTO Universal Applicator Clamping Device | Geomed Medizin-Technik GmbH & Co. KG | 2020 | — |
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 |
|---|---|---|---|
| * | K170203 | System, Applicator, Radionuclide, Remote ControlledSummary page 4…mote Controlled Radionuclide Applicator System Regulatory Class: II 21 CFR Section: 892.5700 Predicate K170203 – Kobold® Prostate HDR Template(s) and Kobold® HDR Stepper Device: Template(s) Reference K052745 – ASSISTO® Ar… | 2017 |
| † | K052745 | Assisto Arm Systems | 2005 |
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 20 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a 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. 2020, 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 ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR
brachytherapy treatment.
Specifically, it is intended to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201279: ASSISTO Universal Applicator Clamping Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201279
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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