510(k) · Cleared

Recalled · 2011

Site-Rite Vision Ultrasound System

K100402510(k) TraditionalCleared Mar 5, 201017-day reviewClass II21 CFR 892.1550Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bard Access Systems, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Mar 5, 2010 as substantially equivalent to K071204 (C.R. Bard, Inc., 2007) and 6 other predicates after a 17-day review. Its family tree reaches back 6 generations to 1995. 10 later devices descend from it. It has been recalled once.

Decided: Mar 5, 2010
Review: 17 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 7

Its longest line of descent runs back 6 generations to K945773 (1995). 29 ancestors in all, the oldest K850478 (1985). 10 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 6 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
5 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
4 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
3 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
2 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
1 generation backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
This deviceK100402 Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010
Descendant · cites it directly · 8 of its ownK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
Descendant · cites it directly · 7 of its ownK132942 Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc. · 2013
Descendant · 2 generations on · 6 of its ownK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
Descendant · 3 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
Descendant · 4 generations on · 2 of its ownK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2012high 2 (2015) · low 0 (2014)2026

Most influential descendants

Showing 5 of 10 · See all

K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012 · cites it directly8descendants
K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc. · 2013 · cites it directly7descendants
K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2015 · 2 generations on6descendants
K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · 3 generations on4descendants
K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K945773	Siemens Sonoline Versa	Siemens Medical Solutions USA, Inc.	1995	—
−5	K020353	Omnia X/XS Ultrasound System	Siemens Medical Systems, Inc.	2002	—
−4	K030949	Titan High Resolution Ultrasound System	Sonosite,Inc.	2003	—
−3	K043559	Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)	Sonosite,Inc.	2005	4
−2	K053069	Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)	Sonosite,Inc.	2005	3
−1	K071134	Sonosite Maxx Series Diagnostic Ultrasound System	Sonosite,Inc.	2007	2
0 (this device)	K100402	Site-Rite Vision Ultrasound System	Bard Access Systems, Inc.	2010	—
+1	K120882	Site Rite Prevue Ultrasound System and Pinpoint Needle Guide	Bard Access Systems, Inc.	2012	—
+1	K132942	Site-Rite Vision II Ultrasound System	C.R. Bard, Inc.	2013	—
+2	K152554	Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT…	C.R. Bard, Inc.	2015	1
+3	K182281	Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT…	C. R. Bard	2018	—
+4	K211193	BD Prevue II Peripheral Vascular Vascular Access System	Bard Access Systems, Inc. (C.R. Bard, Inc.)	2021	—

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
2012	1	0
2013	1	0
2015	2	0
2018	1	0
2021	1	0
2023	1	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K100402, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K071204	Site-Rite 6 Ultrasound System, Model Site-Rite 6 Summary page 1 …sler, Henry Boland Bard Access Systems, Inc. [wholly owned subsidiary of C.R. Bard, Inc.] 605 North 5800 West, Salt Lake City, UT 84116 (801) 522-5000, x5421 or x5428 071204 - Site~Rite® 6 Uitrasound System K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System K053069, K043559 - SonoSite, Inc. High…	C.R. Bard, Inc.	2007	—
*	K071134	Sonosite Maxx Series Diagnostic Ultrasound System Summary page 1 …Inc. [wholly owned subsidiary of C.R. Bard, Inc.] 605 North 5800 West, Salt Lake City, UT 84116 (801) 522-5000, x5421 or x5428 071204 - Site~Rite® 6 Uitrasound System K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System K053069, K043559 - SonoSite, Inc. High-Resclution Ultrasound System (C3 Saries)…	Sonosite,Inc.	2007	2
*	K053069	Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) Summary page 1 …th 5800 West, Salt Lake City, UT 84116 (801) 522-5000, x5421 or x5428 071204 - Site~Rite® 6 Uitrasound System K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System K053069, K043559 - SonoSite, Inc. High-Resclution Ultrasound System (C3 Saries) K043452, K033367, K030949 - SonoSite, Inc. High-Resclutio…	Sonosite,Inc.	2005	3
*	K043559	Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) Summary page 1 …est, Salt Lake City, UT 84116 (801) 522-5000, x5421 or x5428 071204 - Site~Rite® 6 Uitrasound System K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System K053069, K043559 - SonoSite, Inc. High-Resclution Ultrasound System (C3 Saries) K043452, K033367, K030949 - SonoSite, Inc. High-Resclution Ultraso…	Sonosite,Inc.	2005	4
*	K043452	Titan High Resolution Ultrasound System and Sonosite Ultrasound System Summary page 1 …Site~Rite® 6 Uitrasound System K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System K053069, K043559 - SonoSite, Inc. High-Resclution Ultrasound System (C3 Saries) K043452, K033367, K030949 - SonoSite, Inc. High-Resclution Ultrasound System (C2 Serles) Performance standards have not been established…	Sonosite,Inc.	2004	—
*	K033367	Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System… Summary page 1 …e® 6 Uitrasound System K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System K053069, K043559 - SonoSite, Inc. High-Resclution Ultrasound System (C3 Saries) K043452, K033367, K030949 - SonoSite, Inc. High-Resclution Ultrasound System (C2 Serles) Performance standards have not been established by the F…	Sonosite,Inc.	2003	—
*	K030949	Titan High Resolution Ultrasound System Summary page 1 …asound System K071134 - SonoSite, Inc. Maxx™ Series Ultrasound System K053069, K043559 - SonoSite, Inc. High-Resclution Ultrasound System (C3 Saries) K043452, K033367, K030949 - SonoSite, Inc. High-Resclution Ultrasound System (C2 Serles) Performance standards have not been established by the FDA under…	Sonosite,Inc.	2003	—

Also cleared against K071204: 4 other devices →

What descends from it? (10)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K120882	Site Rite Prevue Ultrasound System and Pinpoint Needle Guide	Bard Access Systems, Inc.	2012	8
K132942	Site-Rite Vision II Ultrasound System	C.R. Bard, Inc.	2013	7

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 21, 2011	Not classified	Z-2782-2011	Process control	Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
6 of the 29 ancestors have a recall of any class.
Of its descendants, K120882 (Bard Access Systems, Inc., 2012) has gone furthest, with 8 descendants of its own.
4 other devices also cite its predicate K071204.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)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™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Fetal Abdominal Intraoperative (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…

Read the full statement (172 words)

The Site~Rite Vision™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include:

Fetal

Abdominal

Intraoperative (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™ Ultrasound 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 PICC, CVC, dialysis catheter, port, PIV, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K100402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100402: Site-Rite Vision 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/K100402

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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