510(k) · Cleared
Recalled · Class II · 2019Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 14, 2015 as substantially equivalent to K132942 (C.R. Bard, Inc., 2013) and 2 other predicates after a 97-day review. Its family tree reaches back 8 generations to 1995. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 14, 2015
- Review
- 97 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K945773 (1995). 40 ancestors in all, the oldest K802146 (1980). 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 7 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 6 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 5 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 4 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 3 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 2 generations backK100402 Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010 · Recalled
- 1 generation backK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
- This deviceK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
- Descendant · 2 generations on · 2 of its ownK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021
- Descendant · 3 generations on · 0 of its ownK251673 X9 Ultrasound SystemX9, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243479 EchoGuide (Version 1)Sonavex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK240146 BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · cites it directly4descendants
- K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021 · 2 generations on2descendants
- K251673X9 Ultrasound SystemX9, Inc. · 2025 · 3 generations on0descendants
- K243479EchoGuide (Version 1)Sonavex, Inc. · 2025 · cites it directly0descendants
- K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −7 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −6 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −5 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −4 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −3 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −2 | K100402 | Site-Rite Vision Ultrasound System | Bard Access Systems, Inc. | 2010 | 1 |
| −1 | K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle Guide | Bard Access Systems, Inc. | 2012 | — |
| 0 (this device) | K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT… | C.R. Bard, Inc. | 2015 | — |
| +1 | K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT… | C. R. Bard | 2018 | — |
| +2 | K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021 | — |
| +3 | K251673 | X9 Ultrasound System | X9, Inc. | 2025 | — |
| +1 | K243479 | EchoGuide (Version 1) | Sonavex, Inc. | 2025 | — |
| +3 | K240146 | BD Prevue™ II Peripheral Vascular Access System | Bard Access Systems, Inc. | 2024 | — |
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 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K132942 | Site-Rite Vision II Ultrasound SystemSummary page 7…92.1550, System, Imaging, Pulsed Doppler, Ultrasonic Premarket K132942, concurrence, 17 October 2013 Notification: Manufacturer: Bard Access Systems,… | 2013 |
| * | K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT TechnologySummary page 7…21 CFR 892.1570, Transducer, Ultrasonic, Diagnostic Premarket K142443, concurrence, 30, October, 2014 Notification: Manufacturer: Bard Access Systems… | 2014 |
| * | K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle GuideSummary page 8…10 Premarket K120882, concurrence, 30, May, 2012 Notification: Manufacturer: Bard Access Syste… | 2012 |
What descends from it? (6)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2019 | Class II | Z-0518-2020 | Under Investigation by firm | The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 8 of the 40 ancestors have a recall of any class.
- Of its descendants, K182281 (C. R. Bard, 2018) has gone furthest, with 4 descendants of its own.
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. 2015, 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® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: • Pediatric • Peripheral Vessel • Small Organ (breast, thyroid, parathyroid, testicles) • Musculo-skeletal (conventional and superficial) • Cardiac (adult and pediatric) Typical examinations performed using the Site~Rite® 8 Ultrasound System include: Imaging Applications — Exam Type (Adult and Pediatric) Vascular…
Read the full statement (182 words)
The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:
• Pediatric
• Peripheral Vessel
• Small Organ (breast, thyroid, parathyroid, testicles)
• Musculo-skeletal (conventional and superficial)
• Cardiac (adult and pediatric)
Typical examinations performed using the Site~Rite® 8 Ultrasound System include:
Imaging Applications — Exam Type (Adult and Pediatric)
Vascular: Assessment of vessels in the extremities and neck (e.g., jugular, carotid) leading to or coming from the heart, superficial veins in the arms and legs (e.g., basilic, cephalic, brachial, femoral, radial, saphenous), and vessel mapping. Assessment of superficial thoracic vessels (e.g., axillary, innominate, subclavian)
Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access
Interventional: Guidance for biopsy and drainage
Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures
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/K152554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 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/K152554
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