510(k) · Cleared
ClearedTitan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System, Model L03073, L02245, L02464
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 Nov 5, 2003 as substantially equivalent to K030949 (Sonosite,Inc., 2003) and 3 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1985. 13 later devices descend from it.
- Decided
- Nov 5, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K850478 (1985). 14 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK850478 PLUS 1Dymax Corp · 1985
- 2 generations backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- 1 generation backK021628 Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002
- This deviceK033367 Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System…Sonosite,Inc. · 2003
- 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 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · 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 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| −2 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| −1 | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries) | Sonosite,Inc. | 2002 | — |
| 0 (this device) | K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS… | Sonosite,Inc. | 2003 | — |
| +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 |
|---|---|---|
| 1986 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 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…noSite Ultrasound System that is the subject of this Submission is the collective term for the legally marketed TITANTMHigh-Resolution Ultrasound System (K030949), the Sonosite@ Ultrasound System (PowerSeries) (KO21628), and the Sonosite@Ultrasound System (KO14116).… | 2003 |
| * | K021628 | Sonosite Hand-Caried Untrasound System (Powerseries)Summary page 12…g, and imaging for guidance of biopsy. Imaging to assist in the placement of needles and catheters in vascular or other anatomical structures was previously cleared in K021628. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Prescriptio… | 2002 |
| * | K014116 | Hand-Carried Ultrasound SystemSummary page 14…B and Color Power Doppler, combined B and PowerMap"" Directional Color Power Doppler. 3-D Imaging. Tissue Harmonic Imaging. and imaging for guidance of biopsy cleared m K014116. Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Also included in… | 2001 |
| * | K993624 | Site-Rite 3 Ultrasound SystemSummary page 2…identify use of the designated SonoSite ultrasound systems as substantially equivalent to the clinical application of the Site-Rite 3 Ultrasound System (K993624) marketed by Bard Access Systems for imaging guidance for peripheral nerve block procedures. 4) Device Description:… | 1999 |
What descends from it? (13)
See all 133 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 18 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 14 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 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 guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033367: Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System, Model L03073, L02245, L02464.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033367
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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