510(k) · Cleared
ClearedX9 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X9, Inc. · SGH Ultrasound Imaging For Vascular Access For Hemodialysis
Cleared on Oct 17, 2025 as substantially equivalent to K211193 (Bard Access Systems, Inc. (C.R. Bard, Inc.), 2021) after a 140-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Oct 17, 2025
- Review
- 140 days
- Class
- Class II
- Product code
- SGH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K945773 (1995). 43 ancestors in all, the oldest K802146 (1980). No later device cites it as a predicate yet.
- Root · 11 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 7 generations between
- 3 generations backK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
- 2 generations backK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
- 1 generation backK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021
- This deviceK251673 X9 Ultrasound SystemX9, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 10 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 9 generations backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- 8 generations backK043559 Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 7 generations backK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- 6 generations backK071134 Sonosite Maxx Series Diagnostic Ultrasound SystemSonosite,Inc. · 2007 · Recalled
- 5 generations backK100402 Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010 · Recalled
- 4 generations backK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
- 3 generations backK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
- 2 generations backK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
- 1 generation backK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021
- This deviceK251673 X9 Ultrasound SystemX9, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −10 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −9 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| −8 | K043559 | Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 4 |
| −7 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| −6 | K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | Sonosite,Inc. | 2007 | 2 |
| −5 | K100402 | Site-Rite Vision Ultrasound System | Bard Access Systems, Inc. | 2010 | 1 |
| −4 | K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle Guide | Bard Access Systems, Inc. | 2012 | — |
| −3 | 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 | — |
| −1 | K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021 | — |
| 0 (this device) | K251673 | X9 Ultrasound System | X9, 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 |
| 2013 | 1 | 0 |
| 2014 | 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 SGH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K211193 | BD Prevue II Peripheral Vascular Vascular Access SystemSummary page 5…ices Predicate # Predicate Trade Name Product Code BD Prevue™ II Peripheral IYO – ITX – LLZ K211193 Vascular Access System 4. Device Description Summary The X9 Ultrasound System is intended for guidance in accessing… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 8 companies; a new generation was cleared every 2.7 years on median.
- 9 of the 43 ancestors have a recall of any class.
- 1 other device also cites its predicate K211193.
How does its category compare?
All SGH devicesSGH Ultrasound Imaging For Vascular Access For Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGH
Too few SGH 510(k)s in any year since 2007 to give a median.
Recalls per year · SGH
No recall names SGH since 2007.
Adverse event reports per year · SGH
No MAUDE report names SGH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The X9 Ultrasound System is intended for ultrasound imaging of validated vascular accesses for hemodialysis during the preliminary stage of a cannulation procedure, prior to inserting the needle. The device is intended to be used by qualified healthcare professionals in a medical setting. The device is not intended to be used to diagnose the position of the vascular access without confirming position per standard of care. The X9 Ultrasound System is not for use in pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251673: X9 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251673
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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