510(k) · Cleared
ClearedAlton PT Stepper
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alton Design, LLC · KXK Source, Brachytherapy, Radionuclide
Cleared on Mar 17, 2003 as substantially equivalent to K972152 (Devmed Corp., 1997) and 8 other predicates after an 88-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Mar 17, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 3 generations to K802032 (1980). 13 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 deviceK024183 Alton PT StepperAlton Design, LLC · 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) | K024183 | Alton PT Stepper | Alton Design, LLC | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 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 KXK? 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 KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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…II, CFR 892.1570 VII. Substantial Equivalence: Altonm is substantially equivalent to the classified device and those cleared for marketing by the 510(k) process under K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K- 963302 (Tayman Medical) as… | 1997 |
| * | K011581 | Ameritek Brachytherapy TemplateSummary page 1…II. Substantial Equivalence: Altonm is substantially equivalent to the classified device and those cleared for marketing by the 510(k) process under K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K- 963302 (Tayman Medical) as well as K-972672 an… | 2001 |
| * | K864807 | Teknar Proscan (TM)Summary page 1…, 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 for this product ar… | 1987 |
| * | K871413 | Civco StepperSummary page 1…ubstantially equivalent to the classified device and those cleared for marketing by the 510(k) process under K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K- 963302 (Tayman Medical) as well as K-972672 and KO00960 by Barzell-Whitmeore The "51O… | 1987 |
| * | K913293 | Quick SeederSummary page 1…: 1. These products have the , 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… | 1992 |
| * | K963302 | Tayman Medical, Inc. Stepping & Stabilizing SystemSummary page 1…nd those cleared for marketing by the 510(k) process under K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K- 963302 (Tayman Medical) as well as K-972672 and KO00960 by Barzell-Whitmeore The "51O(k) "Substantial Equivalence" Decision-Making Proc… | 1997 |
| * | K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Summary page 1…510(k) process under K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.) and K- 963302 (Tayman Medical) as well as K-972672 and KO00960 by Barzell-Whitmeore The "51O(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guid… | 1997 |
| * | K000960 | Barzell-Whitmore Maroon Bells, Inc. Colo-Rectal Mover, Model 3900 | 2000 |
| * | K802032 | Mini Mick ApplicatorSummary page 1…cribed below: 1. These products have the , 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… | 1980 |
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 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 2 other devices also cite its predicate K972152.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, 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 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Alton PT Stabilizer and Stepper is designed to allow precision ullrasound probe alignment, precise prostate visualization and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate for other) cancer.
It is also used to allow precision ultrasound alignment and precise prostate visualization in cryotherapy treatments for prostate treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024183 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024183: Alton PT Stepper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024183
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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