510(k) · Cleared
ClearedSite-Rite IV Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dymax Corp · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jul 21, 2003 as substantially equivalent to K993624 (Dymax Corp, 1999) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 1985. 140 later devices descend from it.
- Decided
- Jul 21, 2003
- Review
- 10 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K850478 (1985). 3 ancestors in all. 140 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK850478 PLUS 1Dymax Corp · 1985
- 1 generation backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- This deviceK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
- Descendant · cites it directly · 139 of its ownK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
- Descendant · 2 generations on · 136 of its ownK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
- Descendant · 3 generations on · 64 of its ownK142443 Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014
- Descendant · 3 generations on · 61 of its ownK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- Descendant · 4 generations on · 55 of its ownK152758 Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
Showing 5 of 140 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 140 · See all- K052517Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005 · cites it directly139descendants
- K071204Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007 · 2 generations on136descendants
- K142443Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014 · 3 generations on64descendants
- K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco · 2009 · 3 generations on61descendants
- K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 4 generations on55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| −1 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| 0 (this device) | K032135 | Site-Rite IV Ultrasound System | Dymax Corp | 2003 | — |
| +1 | 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 | — |
| +3 | K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT Technology | C.R. Bard, Inc. | 2014 | — |
| +3 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| +4 | K152758 | Venue 50 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K993624 | Site-Rite 3 Ultrasound SystemSummary page 1…ne 30, 2003 A. LEGALLY MARKETED PREDICATE DEVICES The Site-Rite IV Ultrasound Scanner is substantially equivalent to the Site-Rite 3 Ultrasound Scanner (K993624) and the Dymax Site-Rite II Ultrasound System (cleared as the Dymax Plus 1 Scanner, K862127). B. DEVICE DESCRIPTION… | 1999 |
| * | K862127 | Dymax Personal ScannerSummary page 1…s substantially equivalent to the Site-Rite 3 Ultrasound Scanner (K993624) and the Dymax Site-Rite II Ultrasound System (cleared as the Dymax Plus 1 Scanner, K862127). B. DEVICE DESCRIPTION The Site-Rite IV pulsed echo ultrasound system is a lightweight, low- output, portable,… | 1986 |
What descends from it? (140)
See all 1401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052517 | Site-Rite 5 Ultrasound System | 2005 | 139 |
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 18 years and passes through 1 company; a new generation was cleared every 14.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052517 (C.R. Bard, Inc., 2005) has gone furthest, with 139 descendants of its own.
- 4 other devices also cite its predicate K993624.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Site-Rite IV Ultrasound System with associated probes and accessories provide ultrasound imaging of vascular structures, various organs, and structures of the body. Ultrasound guidance for placement of needles and catheters in these structures or organs may also be performed. The ultrasound guidance may occur either intraoperatively or percutaneously.
The Site-Rite IV Ultrasound System is not intended for ophthalmic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032135: Site-Rite IV 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/K032135
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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