510(k) · Cleared
ClearedAmeritek Brachytherapy Template
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amertek Medical, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 17, 2001 as substantially equivalent to K972152 (Devmed Corp., 1997) and 5 other predicates after a 55-day review. Its family tree reaches back 2 generations to 1980. 3 later devices descend from it.
- Decided
- Jul 17, 2001
- Review
- 55 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K802032 (1980). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK802032 Mini Mick ApplicatorMick Radio-Nuclear Instruments, Inc. · 1980
- 1 generation backK972152 Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997
- This deviceK011581 Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK030518 Ameritek Sure-Point Tracker SystemAmertek Medical, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK024183 Alton PT StepperAlton Design, LLC · 2003
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K802032 | Mini Mick Applicator | Mick Radio-Nuclear Instruments, Inc. | 1980 | — |
| −1 | K972152 | Devmed Stepping and Stabilizing System | Devmed Corp. | 1997 | — |
| 0 (this device) | K011581 | Ameritek Brachytherapy Template | Amertek Medical, Inc. | 2001 | — |
| +1 | K031273 | Ameritek Sure-Point HDR Needle Template | Amertek Medical, Inc. | 2003 | — |
| +1 | K030518 | Ameritek Sure-Point Tracker System | Amertek Medical, Inc. | 2003 | — |
| +1 | K024183 | Alton PT Stepper | Alton Design, LLC | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K972152 | Devmed Stepping and Stabilizing SystemSummary page 1…. to ultrasonic transducer, Class i, CFR 892.1570 VII. Substantial Equivalence: Amertek™ is substantially equivalent (and nearly identical to the device cleared under K-972152. It is sold in sterile form like the Civco Brachytherapy Template cleared under K-970514. It is also equivalent to devices cleare… | 1997 |
| * | K864807 | Teknar Proscan (TM)Summary page 1…intended use, as the equivalent devices the classified device and those cleared for marketing by the 510(k) process under K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above. 2 The technological characteristics for this product are the same as those for the predi… | 1987 |
| * | K871413 | Civco StepperSummary page 1…orm like the Civco Brachytherapy Template cleared under K-970514. It is also equivalent to devices cleared for marketing by the 510(k) process under K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio- Nuc.) and K-963302 (Tayman Medical). The "510(k) "Substantial Equivalence” Decision-Making Proce… | 1987 |
| * | K913293 | Quick SeederSummary page 1…- 1. These products have the same intended use, as the equivalent devices the classified device and those cleared for marketing by the 510(k) process under K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above. 2 The technological characteristics for this product… | 1992 |
| * | K963302 | Tayman Medical, Inc. Stepping & Stabilizing SystemSummary page 1…nder K-970514. It is also equivalent to devices cleared for marketing by the 510(k) process under K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio- Nuc.) and K-963302 (Tayman Medical). The "510(k) "Substantial Equivalence” Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 wa… | 1997 |
| * | K802032 | Mini Mick ApplicatorSummary page 1…ribed below: - 1. These products have the same intended use, as the equivalent devices the classified device and those cleared for marketing by the 510(k) process under K802032 and K913293 (Mick Radio-Nuclear), under K864807 (Teknar Corp.) and others listed above. 2 The technological characteristics for… | 1980 |
| † | K970514 | Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument Guide | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K031273 (Amertek Medical, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K972152.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The Amertek Template is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer.
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/K011581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011581: Ameritek Brachytherapy Template.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011581
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026