510(k) · Cleared
ClearedTitan High Resolution Ultrasound System and Sonosite Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 21, 2004 as substantially equivalent to K030949 (Sonosite,Inc., 2003) and 3 other predicates after a 6-day review. Its family tree reaches back 3 generations to 1995. 11 later devices descend from it.
- Decided
- Dec 21, 2004
- Review
- 6 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K945773 (1995). 10 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK945773 Siemens Sonoline VersaSiemens Medical Solutions USA, Inc. · 1995
- 2 generations backK020353 Omnia X/XS Ultrasound SystemSiemens Medical Systems, Inc. · 2002
- 1 generation backK030949 Titan High Resolution Ultrasound SystemSonosite,Inc. · 2003
- This deviceK043452 Titan High Resolution Ultrasound System and Sonosite Ultrasound SystemSonosite,Inc. · 2004
- Descendant · cites it directly · 10 of its ownK100402 Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 8 of its ownK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK132942 Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc. · 2013
- Descendant · 3 generations on · 6 of its ownK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100402Site-Rite Vision Ultrasound SystemBard Access Systems, Inc. · 2010 · cites it directly10descendants
- K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012 · 2 generations on8descendants
- K132942Site-Rite Vision II Ultrasound SystemC.R. Bard, Inc. · 2013 · 2 generations on7descendants
- K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2015 · 3 generations on6descendants
- K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945773 | Siemens Sonoline Versa | Siemens Medical Solutions USA, Inc. | 1995 | — |
| −2 | K020353 | Omnia X/XS Ultrasound System | Siemens Medical Systems, Inc. | 2002 | — |
| −1 | K030949 | Titan High Resolution Ultrasound System | Sonosite,Inc. | 2003 | — |
| 0 (this device) | K043452 | Titan High Resolution Ultrasound System and Sonosite Ultrasound System | Sonosite,Inc. | 2004 | — |
| +1 | 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 | — |
| +2 | K132942 | Site-Rite Vision II Ultrasound System | C.R. Bard, Inc. | 2013 | — |
| +3 | K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT… | C.R. Bard, Inc. | 2015 | 1 |
| +4 | K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT… | C. R. Bard | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030949 | Titan High Resolution Ultrasound SystemSummary page 2…te Ultrasound System that is the subject of this Submission is the collective term for the legally marketed TITAN TM High-Resolution Ultrasound System (K030949),and the SonoSite® Ultrasound System (K014116). This 510(k) adds the clinical application 'intra-operative (neu… | 2003 |
| * | K014116 | Hand-Carried Ultrasound SystemSummary page 2…sion is the collective term for the legally marketed TITAN TM High-Resolution Ultrasound System (K030949),and the SonoSite® Ultrasound System (K014116). This 510(k) adds the clinical application 'intra-operative (neurological)' as a indication to the SonoSite Ul… | 2001 |
| * | K020353 | Omnia X/XS Ultrasound SystemSummary page 2…evices that have 'intra-operative (neurological)' as a clinical application or indication are Siemens SONOLINE Omnia X/XS Diagnostic Ultrasound System (K020353) and Advanced Technology Laboratories HDI 5000 Ultrasound System (KO1 1224) 4) Device Description:… | 2002 |
| * | K011224 | Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and… | 2001 |
| † | K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System… | 2003 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100402 | Site-Rite Vision Ultrasound System | 2010 | 10 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K100402 (Bard Access Systems, Inc., 2010) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K030949.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The SonoSite Ultrasound Systems are intended for use for ultrasound evaluation of fetal - OB/GYN, abdominal, intra-operative (abdominal organs, neurological, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN Ultrasound System has been additionally…
Read the full statement (88 words)
The SonoSite Ultrasound Systems are intended for use for ultrasound evaluation of fetal - OB/GYN, abdominal, intra-operative (abdominal organs, neurological, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for biopsy guidance, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and imaging guidance for peripheral nerve block procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043452: Titan High Resolution Ultrasound System and Sonosite Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043452
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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