510(k) · Cleared
ClearedSite-Rite Vision II Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 17, 2013 as substantially equivalent to K100402 (Bard Access Systems, Inc., 2010) after a 28-day review. Its family tree reaches back 7 generations to 1995. 7 later devices descend from it.
- Decided
- Oct 17, 2013
- Review
- 28 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945773 (1995). 30 ancestors in all, the oldest K850478 (1985). 7 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 6 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 5 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 4 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 3 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 2 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 1 generation backK100402 Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010 · Recalled
- This deviceK132942 Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
- Descendant · 3 generations on · 2 of its ownK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021
- Descendant · 4 generations on · 0 of its ownK251673 X9 Ultrasound SystemX9, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243479 EchoGuide (Version 1)Sonavex, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2015 · cites it directly6descendants
- K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · 2 generations on4descendants
- K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021 · 3 generations on2descendants
- K251673X9 Ultrasound SystemX9, Inc. · 2025 · 4 generations on0descendants
- K243479EchoGuide (Version 1)Sonavex, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −6 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −5 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −4 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −3 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −2 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −1 | K100402 | Site-Rite Vision Ultrasound System | Bard Access Systems, Inc. | 2010 | 1 |
| 0 (this device) | K132942 | Site-Rite Vision II Ultrasound System | C.R. Bard, Inc. | 2013 | — |
| +1 | K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT… | C.R. Bard, Inc. | 2015 | 1 |
| +2 | K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT… | C. R. Bard | 2018 | — |
| +3 | K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021 | — |
| +4 | K251673 | X9 Ultrasound System | X9, Inc. | 2025 | — |
| +2 | K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K100402 | Site-Rite Vision Ultrasound SystemSummary page 2…LLZ 21 CFR 892.2050 System, image processing, radiological Premarket K100402, concurrence date 05 March 2010 Notification: Manufacturer:… | 2010 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology | 2015 | 6 |
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 5 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 30 ancestors have a recall of any class.
- Of its descendants, K152554 (C.R. Bard, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K100402.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Site-Rite Vision* 11Ultrasound System is intended for diagnostic ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications include: * Fetal * Abdominal * Intra-operative (semi-critical†) * Pediatric * Peripheral Vessel * Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) * Musculo-skeletal (conventional and Superficial) * Cardiac (adult and pediatric) Typical examinations performed using…
Read the full statement (180 words)
The Site-Rite Vision* 11Ultrasound System is intended for diagnostic ultrasound imaging or fluid-flow analysis of the human body. Specific clinical applications include:
* Fetal
* Abdominal
* Intra-operative (semi-critical†)
* Pediatric
* Peripheral Vessel
* Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary)
* Musculo-skeletal (conventional and Superficial)
* Cardiac (adult and pediatric)
Typical examinations performed using the Site-Rite Vision* 11Ultrasound System include:
Imaging Applications — Exam Type (adult & pediatric)
Vascular: Assessment of carotid arteries, aorta, deep veins, superficial veins in the arms and legs, select small vessels supporting organs
Vascular Access: Guidance for a PICC, CVC, dialysis catheter, port, PICC, and arterial-line placement, and peripheral vein and artery access
Abdominal: Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, appendix, and surrounding anatomical structures
Interventional and Intraoperative: Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperative procedures (semi-critical†)
Superficial: Assessment of breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal procedures, soft tissue structures, and surrounding anatomical structures
† Semi-critical is defined as clinical applications in which the probe contacts mucous membranes or non-intact skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132942: Site-Rite Vision II 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/K132942
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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