510(k) · Cleared

Cleared

Site-Rite 6 Ultrasound System with Pinpoint GT Technology

K142443510(k) TraditionalCleared Oct 30, 201458-day reviewClass II21 CFR 892.1560

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

C.R. Bard, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Oct 30, 2014 as substantially equivalent to K071204 (C.R. Bard, Inc., 2007) after a 58-day review. Its family tree reaches back 5 generations to 1985. 64 later devices descend from it.

Decided: Oct 30, 2014
Review: 58 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K850478 (1985). 6 ancestors in all. 64 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK850478 PLUS 1Dymax Corp · 1985
4 generations backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
3 generations backK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
2 generations backK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
1 generation backK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
This deviceK142443 Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014
Descendant · cites it directly · 55 of its ownK152758 Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
Descendant · 2 generations on · 47 of its ownK160277 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
Descendant · 3 generations on · 46 of its ownK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
Descendant · 2 generations on · 35 of its ownK170714 VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017
Descendant · 3 generations on · 28 of its ownK180599 VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2015high 10 (2020) · low 2 (2015)2026

Most influential descendants

Showing 5 of 64 · See all

K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · cites it directly55descendants
K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · 2 generations on47descendants
K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016 · 3 generations on46descendants
K170714VenueGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · 2 generations on35descendants
K180599VenueGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · 3 generations on28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K850478	PLUS 1	Dymax Corp	1985	—
−4	K993624	Site-Rite 3 Ultrasound System	Dymax Corp	1999	—
−3	K032135	Site-Rite IV Ultrasound System	Dymax Corp	2003	—
−2	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	—
0 (this device)	K142443	Site-Rite 6 Ultrasound System with Pinpoint GT Technology	C.R. Bard, Inc.	2014	—
+1	K152758	Venue 50	GE Medical Systems Ultrasound and Primary Care Diagnostics	2015	—
+2	K160277	LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6	GE Medical Systems Ultrasound and Primary Care Diagnostics	2016	—
+3	K161706	Vivid iq	Ge Medical Systems Ultrasound and Primary Care Diagnostics L	2016	—
+2	K170714	Venue	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC	2017	—
+3	K180599	Venue	GE Medical Systems Ultrasound and Primary Care Diagnostics	2018	—

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
2015	2	0
2016	2	0
2017	3	0
2018	6	0
2019	3	0
2020	10	0
2021	6	0
2022	9	0
2023	5	0
2024	7	0
2025	7	0
2026	4	0

FIG. 1 — Lineage of K142443, 1985–2026Source: 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 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K071204	Site-Rite 6 Ultrasound System, Model Site-Rite 6 Summary page 6 …Ultrasonic ITX, 21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic Premarket K071204, concurrence, 18 May 2007 Notification: Manufacturer: Bard Access Systems,…	C.R. Bard, Inc.	2007	—
†	K132942	Site-Rite Vision II Ultrasound System	C.R. Bard, Inc.	2013	—
†	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1
†	K092619	Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…	Civco	2009	17

Also cleared against K071204: 4 other devices →

What descends from it? (64)

See all 64

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

Number	Device	Applicant	Decided	Descendants
K152758	Venue 50	GE Medical Systems Ultrasound and Primary Care Diagnostics	2015	55
K152554	Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology	C.R. Bard, Inc.	2015	6
K203657	Vu-Path Ultrasound System	Crystalline Medical	2021	0

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 29 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K152758 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2015) has gone furthest, with 55 descendants of its own.
4 other devices also cite its predicate K071204.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)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® 6 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.

Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142443 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142443: Site-Rite 6 Ultrasound System with Pinpoint GT Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142443

Report an extraction error

Are you the manufacturer?

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