510(k) · Cleared
ClearedReusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koelis · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 31, 2017 as substantially equivalent to K093713 (Civco Medical Instruments, 2010) and 1 other predicate after a 116-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Jul 31, 2017
- Review
- 116 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K850478 (1985). 15 ancestors in all, the oldest K850571 (1985). No later device cites it as a predicate yet.
- Root · 6 generations backK850478 PLUS 1Dymax Corp · 1985
- 5 generations backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- 4 generations backK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
- 3 generations backK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
- 2 generations backK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
- 1 generation backK093713 Ultrasound General Purpose Guidance SystemCivco Medical Instruments · 2010 · Recalled
- This deviceK171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and…Koelis · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| −5 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| −4 | K032135 | Site-Rite IV Ultrasound System | Dymax Corp | 2003 | — |
| −3 | K052517 | Site-Rite 5 Ultrasound System | C.R. Bard, Inc. | 2005 | — |
| −2 | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6 | C.R. Bard, Inc. | 2007 | — |
| −1 | K093713 | Ultrasound General Purpose Guidance System | Civco Medical Instruments | 2010 | 7 |
| 0 (this device) | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093713 | Ultrasound General Purpose Guidance SystemSummary page 4…E range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are substantially equivalent to: 510(k) Number Device Name K093713 Ultrasound General Purpose Guidance System K131161 A… | 2010 |
| * | K131161 | EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…Summary page 4…ally equivalent to: 510(k) Number Device Name K093713 Ultrasound General Purpose Guidance System K131161 AccuCARETM product line Intended Use: The reusable guides ranges (PERINE range, NAIL range… | 2013 |
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 32 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 3 other devices also cite its predicate K093713.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions. I. Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and…
Read the full statement (150 words)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions.
I. Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment.
l.a. CON-LEAD range and LIN-LEAD range
The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment.
1.b. PERINE range
The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males.
2. Steady Pro range
The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.
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/K171040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171040: Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171040
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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