510(k) · Cleared
ClearedAmeritek Sure-Point HDR Needle Template
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amertek Medical, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jul 15, 2003 as substantially equivalent to K011581 (Amertek Medical, Inc., 2001) and 4 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Jul 15, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K802032 (1980). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK802032 Mini Mick ApplicatorMick Radio-Nuclear Instruments, Inc. · 1980
- 2 generations backK972152 Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997
- 1 generation backK011581 Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001
- This deviceK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K802032 | Mini Mick Applicator | Mick Radio-Nuclear Instruments, Inc. | 1980 | — |
| −2 | K972152 | Devmed Stepping and Stabilizing System | Devmed Corp. | 1997 | — |
| −1 | K011581 | Ameritek Brachytherapy Template | Amertek Medical, Inc. | 2001 | — |
| 0 (this device) | K031273 | Ameritek Sure-Point HDR Needle Template | Amertek Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K011581 | Ameritek Brachytherapy Template | 2001 |
| * | K003270 | Prostate Stepper Template Set, Model Part Number 189,065,189,066,189,067Summary page 1…eedle Template is substantially equivalent to its predicate device, Sure-Point Brachytherapy Template cleared under KO11581. and to HDR templates cleared by Nucletron in K003270, Mick Radio-Nuclear in K993400, and related devices. The "51O(k) "Substantial Equivalence" Decision-Making Process (Detailed) fr… | 2000 |
| * | K993400 | HDR Contour TP Template and Implant AccessoriesSummary page 1…equivalent to its predicate device, Sure-Point Brachytherapy Template cleared under KO11581. and to HDR templates cleared by Nucletron in K003270, Mick Radio-Nuclear in K993400, and related devices. The "51O(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-… | 2000 |
| * | K990990 | Cet Prostate Applicator Set, Part Number 089.066Summary page 1…as described below: 1. These products have the same intended use, as the equivalent devices cleared for marketing by the 5lO(k) process under KO03270 and K990990 by Nucletron, K993400 by Mick Radio-Nuclear Instruments, and K910862 by Best industries. 2. The technological char… | 1999 |
| * | K910862 | Various Template ApplicatorsSummary page 1…s the equivalent devices cleared for marketing by the 5lO(k) process under KO03270 and K990990 by Nucletron, K993400 by Mick Radio-Nuclear Instruments, and K910862 by Best industries. 2. The technological characteristics for this product are the same as those for the predicate… | 1991 |
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 23 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 17 ancestors have a recall of any class.
- 2 other devices also cite its predicate K011581.
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.
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 use of sealed radioisotopes to treat tumors within the body ha:: been documented and published since the turn of the century. Modem era radiation therapy has developed delivery systems using isotopes-of cesium, indium, iodine and gold, for a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. The two common modalities are the Low dose rate and High dose rate afterloaders. The…
Read the full statement (117 words)
The use of sealed radioisotopes to treat tumors within the body ha:: been documented and published since the turn of the century. Modem era radiation therapy has developed delivery systems using isotopes-of cesium, indium, iodine and gold, for a few examples. Many tumors now are treated by internal exposure to radiation emitted from sealed radioactive sources. The two common modalities are the Low dose rate and High dose rate afterloaders.
The Sure-Pointm HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031273 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031273: Ameritek Sure-Point HDR Needle Template.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031273
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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