510(k) Report

510(k) · Cleared

Cleared

Site-Rite 6 Ultrasound System, Model Site-Rite 6

K071204510(k) SpecialCleared May 18, 200717-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 May 18, 2007 as substantially equivalent to K052517 (C.R. Bard, Inc., 2005) after a 17-day review. Its family tree reaches back 4 generations to 1985. 136 later devices descend from it.

Decided
May 18, 2007
Review
17 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K850478 (1985). 5 ancestors in all. 136 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1986: 1 other ancestor2009: 1 descendant cleared2010: 2 descendants cleared2012: 3 descendants cleared2014: 4 descendants cleared2013: 2 descendants cleared2011: 1 descendant cleared2015: 5 descendants cleared2017: 8 descendants cleared2026: 11 descendants cleared2021: 11 descendants cleared2025: 12 descendants cleared2018: 13 descendants cleared2016: 3 descendants cleared2020: 18 descendants cleared2019: 9 descendants cleared2023: 8 descendants cleared2022: 15 descendants cleared2024: 10 descendants clearedK850478 · PLUS 1 · Dymax Corp · 1985K993624 · Site-Rite 3 Ultrasound System · Dymax Corp · 1999K032135 · Site-Rite IV Ultrasound System · Dymax Corp · 2003K052517 · Site-Rite 5 Ultrasound System · C.R. Bard, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 15 descendants3 generations forward: 8 descendants4 generations forward: 13 descendants5 generations forward: 21 descendants6 generations forward: 21 descendants7 generations forward: 22 descendants8 generations forward: 16 descendants9 generations forward: 6 descendants10 generations forward: 4 descendants11 generations forward: 3 descendants12 generations forward: 2 descendants K052517 · Site-Rite 5 Ultrasound System · C.R. Bard, Inc. · 2005K032135 · Site-Rite IV Ultrasound System · Dymax Corp · 2003K993624 · Site-Rite 3 Ultrasound System · Dymax Corp · 1999K850478 · PLUS 1 · Dymax Corp · 19850+5+10
  1. Root · 4 generations backK850478 PLUS 1Dymax Corp · 1985
  2. 3 generations backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
  3. 2 generations backK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
  4. 1 generation backK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
  5. This deviceK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
  6. Descendant · cites it directly · 64 of its ownK142443 Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014
  7. Descendant · cites it directly · 61 of its ownK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
  8. Descendant · 2 generations on · 55 of its ownK152758 Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015
  9. Descendant · 3 generations on · 47 of its ownK160277 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
  10. Descendant · 4 generations on · 46 of its ownK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016

Showing 5 of 136 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 12012: 32013: 22014: 42015: 52016: 32017: 82018: 132019: 92020: 182021: 112022: 152023: 82024: 102025: 122026: 11
2009high 18 (2020) · low 1 (2009)2026

Most influential descendants

Showing 5 of 136 · See all
  • K142443Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2014 · cites it directly64descendants
  • K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco · 2009 · cites it directly61descendants
  • K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · 2 generations on55descendants
  • K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016 · 3 generations on47descendants
  • K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016 · 4 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K850478PLUS 1Dymax Corp1985—
−3K993624Site-Rite 3 Ultrasound SystemDymax Corp1999—
−2K032135Site-Rite IV Ultrasound SystemDymax Corp2003—
−1K052517Site-Rite 5 Ultrasound SystemC.R. Bard, Inc.2005—
0 (this device)K071204Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc.2007—
+1K142443Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.2014—
+1K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax…Civco200917
+2K152758Venue 50GE Medical Systems Ultrasound and Primary Care Diagnostics2015—
+3K160277LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6GE Medical Systems Ultrasound and Primary Care Diagnostics2016—
+4K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201110
201230
201320
201440
201550
201630
201780
2018130
201990
2020180
2021110
2022150
202380
2024100
2025120
2026110
FIG. 1 — Lineage of K071204, 1985–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K052517Site-Rite 5 Ultrasound System
Summary page 1
…lia Earhart Drive Salt Lake City, UT 84116 (801) 595-0700, x5421 (phone) Predicate device: K052517, Site-Rite® 5 Ultrasound System Performance Standards: Performance standards have not been established by the FDA under…
C.R. Bard, Inc.2005—

Also cleared against K052517: 1 other device →

What descends from it? (136)

See all 136

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

NumberDeviceApplicantDecidedDescendants
K142443Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc.201464
K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco200961
K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc.201010
K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc.20128
K093713Ultrasound General Purpose Guidance SystemCivco Medical Instruments20104

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 22 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K142443 (C.R. Bard, Inc., 2014) has gone furthest, with 64 descendants of its own.
  • 1 other device also cites its predicate K052517.

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. 2007, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
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

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

The Site-Rite®6 UltrasoundSystem with associatedprobe and accessoriesprovide ultrasound guidancefor placement of needles and catheters in vascular structures. Ultrasoundguidance may occur intraoperativelyor percutaneously. Ultrasoundimaging of vascular structures, various organs and structures of the body may also be performed

Indications for use as stated in the FDA summary.

Also cleared against K052517

1 other device cites the same predicate.

  • K070515A-View Basic and PlusCordatec N.V. · 2007

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in IYO

The IYO category page

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  • K260605Lilium one (USM330)Lilium Otsuka Co., Ltd. · 2026
  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K071204 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071204

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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