510(k) · Cleared
ClearedSite-Rite 5 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 29, 2005 as substantially equivalent to K032135 (Dymax Corp, 2003) after a 15-day review. Its family tree reaches back 3 generations to 1985. 139 later devices descend from it.
- Decided
- Sep 29, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K850478 (1985). 4 ancestors in all. 139 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK850478 PLUS 1Dymax Corp · 1985
- 2 generations backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- 1 generation backK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
- This deviceK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
- Descendant · cites it directly · 136 of its ownK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
- Descendant · 2 generations on · 64 of its ownK142443 Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014
- Descendant · 2 generations on · 61 of its ownK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- Descendant · 3 generations on · 55 of its ownK152758 Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
- Descendant · 4 generations on · 47 of its ownK160277 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
Showing 5 of 139 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 139 · See all- K071204Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007 · cites it directly136descendants
- K142443Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014 · 2 generations on64descendants
- K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco · 2009 · 2 generations on61descendants
- K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 3 generations on55descendants
- K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · 4 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| −2 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| −1 | K032135 | Site-Rite IV Ultrasound System | Dymax Corp | 2003 | — |
| 0 (this device) | K052517 | Site-Rite 5 Ultrasound System | C.R. Bard, Inc. | 2005 | — |
| +1 | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6 | C.R. Bard, Inc. | 2007 | — |
| +2 | K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT Technology | C.R. Bard, Inc. | 2014 | — |
| +2 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| +3 | K152758 | Venue 50 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | — |
| +4 | K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 18 | 0 |
| 2021 | 11 | 0 |
| 2022 | 15 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K032135 | Site-Rite IV Ultrasound SystemSummary page 3…1570 - Class 1/ Diagnostic Device Classification Panel: Radiology Devices Panel Premarket Notification: K032135, concurrence date July 21, 2003 5.6 Device Description The Site-Rite®(5 Ultrasound System is a lightweight, low-outpu… | 2003 |
What descends from it? (139)
See all 1392 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 20 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K071204 (C.R. Bard, Inc., 2007) has gone furthest, with 136 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 Site-Rite®5 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052517: Site-Rite 5 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052517
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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