510(k) · Cleared
Recalled · Class II · 2018Ilook 25 Needle Guide Attachment and Bracket Assembly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jan 22, 2003 after a 15-day review. The FDA summary names its predicate without a number. 69 later devices descend from it. It has been recalled 16 times.
- Decided
- Jan 22, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 16
- Predicates
- 0
69 later devices descend from it, 3 citing it directly.
- This deviceK030064 Ilook 25 Needle Guide Attachment and Bracket AssemblySonosite,Inc. · 2003
- Descendant · cites it directly · 61 of its ownK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- Descendant · 2 generations on · 39 of its ownK141459 Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014
- Descendant · 3 generations on · 34 of its ownK151451 Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · Recalled
- Descendant · 4 generations on · 23 of its ownK161843 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · Recalled
- Descendant · 4 generations on · 22 of its ownK163702 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation · 2017 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K092619Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Civco · 2009 · cites it directly61descendants
- K141459Aplio 500/400/300 Diagnostic Ultrasound System, V5.0Toshibamedical Systems Corporation · 2014 · 2 generations on39descendants
- K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0Toshibamedical Systems Corporation · 2015 · 3 generations on34descendants
- K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0Toshibamedical Systems Corporation · 2016 · 4 generations on23descendants
- K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1Toshibamedical Systems Corporation · 2017 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030064 | Ilook 25 Needle Guide Attachment and Bracket Assembly | Sonosite,Inc. | 2003 | — |
| +1 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| +2 | K141459 | Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 | Toshibamedical Systems Corporation | 2014 | — |
| +3 | K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | 2015 | 2 |
| +4 | K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | Toshibamedical Systems Corporation | 2016 | 1 |
| +4 | K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | Toshibamedical Systems Corporation | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Site-Rite Disposable Needle Guides with Bracket Integral to Transducer Named without a submission number | |
| * | — | C N C O Sterile Ultra Pro II Needle Guides and Bracket Named without a submission number |
What descends from it? (69)
See all 693 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 2, 2018 | Class II | Z-0563-2019 | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. |
| Nov 2, 2018 | Class II | Z-0574-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0576-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0566-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0569-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0575-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0571-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0562-2019 | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. |
| Nov 2, 2018 | Class II | Z-0564-2019 | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. |
| Nov 2, 2018 | Class II | Z-0565-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0567-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0568-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0570-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0572-2019 | Other | |
| Nov 2, 2018 | Class II | Z-0573-2019 | Other | |
| Dec 12, 2005 | Not classified | Z-0407-06 | Other | 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides. |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092619 (Civco, 2009) has gone furthest, with 61 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The intended use of the iLookTM25 Needle Guide Attachment and Bracket Assembly when used in conjunction with the Ultrasound System and attached to the Ultrasound System's transducer is to facilitate proper needle placement to various depths in vascular or other anatomical structures from the transducer surface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030064: Ilook 25 Needle Guide Attachment and Bracket Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030064
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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