510(k) · Cleared
ClearedEX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch LP, Mulit-Purpose Workstation,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CIVCO Medical Instruments Co., Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 17, 2013 as substantially equivalent to K972672 (Barzell-Whitmore Maroon Bells, Inc., 1997) after a 146-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.
- Decided
- Sep 17, 2013
- Review
- 146 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850571 (1985). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK850571 I-125 Implant GunMick Radio-Nuclear Instruments, Inc. · 1985
- 1 generation backK972672 Brachystepper Stepping Unit, Brachystepper Needle Guide Template…Barzell-Whitmore Maroon Bells, Inc. · 1997
- This deviceK131161 EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper…CIVCO Medical Instruments Co., Inc. · 2013
- Descendant · cites it directly · 0 of its ownK171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and…Koelis · 2017
Most influential descendants
Showing 1 of 1 · See all- K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850571 | I-125 Implant Gun | Mick Radio-Nuclear Instruments, Inc. | 1985 | — |
| −1 | K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand… | Barzell-Whitmore Maroon Bells, Inc. | 1997 | — |
| 0 (this device) | K131161 | EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch… | CIVCO Medical Instruments Co., Inc. | 2013 | — |
| +1 | K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD… | Koelis | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Summary page 1…in the flowing 510(k)s: Predicate Devices Mfg K972672: Brachystepper Stepping Unit, Brachystand Support and Barzell-Whitmore Maroon Manual Adjustment Acc… | 1997 |
| Kept off the family tree | K981873 | Brachystepper Disposable Template Grid Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…WW.CIVCOCOMv Predicate Devices Mfg K981873: Brachystepper m Disposable Template Grid Barzell-Whitmore Maroon… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and… | 2017 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 16.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K171040 (Koelis, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K972672.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
This device is indicated for use in adult males with known or suspected prostate cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131161: EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch LP, Mulit-Purpose Workstation,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131161
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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