510(k) · Cleared
Recalled · 2006Tayman Medical, Inc. Stepping & Stabilizing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tayman Medical, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Feb 6, 1997 after a 168-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled once.
- Decided
- Feb 6, 1997
- Review
- 168 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 5 citing it directly.
- This deviceK963302 Tayman Medical, Inc. Stepping & Stabilizing SystemTayman Medical, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK972152 Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997
- Descendant · cites it directly · 3 of its ownK011581 Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK982696 InterplantBurdette Medical Systems, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK131428 RadvisionAcoustic Medsystems, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK031273 Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K972152Devmed Stepping and Stabilizing SystemDevmed Corp. · 1997 · cites it directly4descendants
- K011581Ameritek Brachytherapy TemplateAmertek Medical, Inc. · 2001 · cites it directly3descendants
- K982696InterplantBurdette Medical Systems, Inc. · 1999 · cites it directly1descendant
- K131428RadvisionAcoustic Medsystems, Inc. · 2013 · 2 generations on0descendants
- K031273Ameritek Sure-Point HDR Needle TemplateAmertek Medical, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963302 | Tayman Medical, Inc. Stepping & Stabilizing System | Tayman Medical, Inc. | 1997 | — |
| +1 | K972152 | Devmed Stepping and Stabilizing System | Devmed Corp. | 1997 | — |
| +1 | K011581 | Ameritek Brachytherapy Template | Amertek Medical, Inc. | 2001 | — |
| +1 | K982696 | Interplant | Burdette Medical Systems, Inc. | 1999 | 1 |
| +2 | K131428 | Radvision | Acoustic Medsystems, Inc. | 2013 | — |
| +2 | K031273 | Ameritek Sure-Point HDR Needle Template | Amertek Medical, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | — | Teknar, Inc. Seeding device Named without a submission number |
What descends from it? (7)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2006 | Not classified | Z-0221-2007 | Other | The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972152 (Devmed Corp., 1997) has gone furthest, with 4 descendants of its own.
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 Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate 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/K963302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963302: Tayman Medical, Inc. Stepping & Stabilizing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963302
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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