510(k) · Cleared
ClearedSite~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C. R. Bard · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 24, 2018 as substantially equivalent to K152554 (C.R. Bard, Inc., 2015) after a 62-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 24, 2018
- Review
- 62 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945773 (1995). 41 ancestors in all, the oldest K802146 (1980). 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 5 generations between
- 3 generations backK100402 Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010 · Recalled
- 2 generations backK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
- 1 generation backK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
- This deviceK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
- Descendant · cites it directly · 2 of its ownK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021
- Descendant · 2 generations on · 0 of its ownK251673 X9 Ultrasound SystemX9, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240146 BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231283 SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2023
Show all 9 generations
- Root · 9 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 8 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 7 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 6 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 5 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 4 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 3 generations backK100402 Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010 · Recalled
- 2 generations backK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
- 1 generation backK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
- This deviceK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
Most influential descendants
Showing 4 of 4 · See all- K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021 · cites it directly2descendants
- K251673X9 Ultrasound SystemX9, Inc. · 2025 · 2 generations on0descendants
- K240146BD Prevue™ II Peripheral Vascular Access SystemBard Access Systems, Inc. · 2024 · 2 generations on0descendants
- K231283SiteRite™ 9 Ultrasound SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −8 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −7 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −6 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −5 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −4 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −3 | K100402 | Site-Rite Vision Ultrasound System | Bard Access Systems, Inc. | 2010 | 1 |
| −2 | 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 |
| 0 (this device) | K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT… | C. R. Bard | 2018 | — |
| +1 | K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021 | — |
| +2 | K251673 | X9 Ultrasound System | X9, Inc. | 2025 | — |
| +2 | K240146 | BD Prevue™ II Peripheral Vascular Access System | Bard Access Systems, Inc. | 2024 | — |
| +1 | K231283 | SiteRite™ 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2023 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologySummary page 8…Regulatory Class: Class II FDA Product Code: IYO, ITX, LLZ 3. Predicate Device and Reference Device Predicate Device 510(k) Number: K152554 Name of Device: Site~Rite® 8 Ultrasound System with Pinpoint™ GT Needle Technology Owne… | 2015 |
| † | K140254 | EZONO 4000 | 2014 |
What descends from it? (4)
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 23 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 9 of the 41 ancestors have a recall of any class.
- Of its descendants, K211193 (Bard Access Systems, Inc. (C.R. Bard, Inc.), 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K152554.
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. 2018, 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 and Vascular Access • 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: Vascular: Assessment of vessels in the…
Read the full statement (176 words)
The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include:
• Pediatric
• Peripheral Vessel and Vascular Access
• 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:
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, musculoskeletal procedures (e.g., joints, ligaments, tendons), soft tissue structures, and surrounding anatomical structures
Cue™ Needle Tracking System and Pinpoint™ GT Needle Technology are each intended to provide visual needle tracking to assist with ultrasound guided vascular access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182281
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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