# K030064: Ilook 25 Needle Guide Attachment and Bracket Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Sonosite,Inc.
- Decided: Jan 22, 2003 after 15 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
69 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Site-Rite Disposable Needle Guides with Bracket Integral to Transducer: named in the summary without a submission number
- (no number) C N C O Sterile Ultra Pro II Needle Guides and Bracket: named in the summary without a submission number

## Most influential descendants
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker (2009), 61 descendants of its own
- K141459: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 (2014), 39 descendants of its own
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (2015), 34 descendants of its own
- K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (2016), 23 descendants of its own
- K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (2017), 22 descendants of its own

## Recalls of this device
- Nov 2, 2018 · Class II · Z-0563-2019: 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: 
- Nov 2, 2018 · Class II · Z-0576-2019: 
- Nov 2, 2018 · Class II · Z-0566-2019: 
- Nov 2, 2018 · Class II · Z-0569-2019: 
- Nov 2, 2018 · Class II · Z-0575-2019: 
- Nov 2, 2018 · Class II · Z-0571-2019: 
- Nov 2, 2018 · Class II · Z-0562-2019: 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: 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: 
- Nov 2, 2018 · Class II · Z-0567-2019: 
- Nov 2, 2018 · Class II · Z-0568-2019: 
- Nov 2, 2018 · Class II · Z-0570-2019: 
- Nov 2, 2018 · Class II · Z-0572-2019: 
- Nov 2, 2018 · Class II · Z-0573-2019: 
- Dec 12, 2005 · Not classified · Z-0407-06: 22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.

## Indications for use
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.

Source page: https://510kreport.com/device/K030064
Methodology: https://510kreport.com/methodology