510(k) · Cleared
ClearedSite Rite Prevue Ultrasound System and Pinpoint Needle Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Access Systems, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 30, 2012 as substantially equivalent to K100402 (Bard Access Systems, Inc., 2010) and 4 other predicates after a 68-day review. Its family tree reaches back 7 generations to 1995. 8 later devices descend from it.
- Decided
- May 30, 2012
- Review
- 68 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K945773 (1995). 37 ancestors in all, the oldest K802146 (1980). 8 later devices descend from it, 2 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 deviceK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
- 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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) | K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle Guide | Bard Access Systems, Inc. | 2012 | — |
| +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 |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 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 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? (5)
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 1…ducers LLZ 21 CFR 892.2050 Picture Archiving and Communications System Premarket Notification: K100402, concurrence date 05 March 2010 Manufacturer: Bard Access Systems, Inc. T… | 2010 |
| * | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6Summary page 1…d Echo Imaging System ITX 21 CER 892.1570 Diagnostic Ultrasonic Transducers Premarket Notification: K07 1204, concurrence date 18 May 2007 Manufacturer: Bard Access Systems, Inc. Subject Device Trad… | 2007 |
| * | K072515 | Embrace GelSummary page 2…el Pad Devices Classification Name: MUI 21 CFR 892.1570 Diagnostic Ultrasonic Transducer Premarket Notification: K072515, concurrence date 20 September 2007 Manufacturer: Orison Corporation… | 2007 |
| * | K031894 | Scantec PadSummary page 2…canTacTM Pad Classification Name: MUI 21 CEFR 892.1570 Diagnostic Ultrasonic Transducers Premarket Notification: K031894, concurrence date 18 July 2003 Manufacturer: SONOTECH, Inc. Subject Device Trade… | 2003 |
| * | K042445 | Site-Rite Needle Guide Kits and Probe Cover KitSummary page 2…robe Cover Kit Classification Name: TX 21 CFR 892.1570 Diagnostic Ultrasonic Transducers Premarket Notification: K042445, concurrence date 19 October 2004 Manufacturer Bard Access Systems, Inc. Device -… | 2004 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 8 of the 37 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 IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include:
*Adult Cephalic
*Neonatal Cephalic
*Pediatric
.Peripheral Vessel
The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue* Ultrasound System. The device is intended for use with pediatrics and adults.I
The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120882 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120882
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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