# K260161: SmartGuide Disposable Guides and Grids

- Pathway: 510(k) (Traditional)
- Applicant: UC-CARE, Ltd.
- Decided: Jul 30, 2026 after 191 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875128 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223689: Disposable Needle Guides and Grids, Advance Medical Designs, Inc. (2023) Summary page 5.

## Indications for use
SmartGuide Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention by providing fixed guiding for the precise insertion of linear instruments, such as needles. The Needle Guides and Grids are designed to aid adult patient population, in need of a biopsy, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.

Source page: https://510kreport.com/device/K260161
Methodology: https://510kreport.com/methodology