# K250469: Accuro® 3S Needle Guide Kit

- Pathway: 510(k) (Traditional)
- Applicant: Rivanna Medical, Inc.
- Decided: Jun 13, 2025 after 115 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: 4 generations back to K844472 (1985). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171348: Pinpoint GT Needle Guide Kits, C.R. Bard, Inc. (2017) Summary page 5.

## Most influential descendants
- K261014: Accuro® 3S Needle Guide Kit (2026), 0 descendants of its own

## Indications for use
The Accuro® 3S Needle Guide Kit is intended to be used with the Accuro® 3S diagnostic ultrasound imaging system. The Accuro® 3S Needle Guide Kit supports alignment of a needle with the ultrasound imaging plane to assist the healthcare professional in placing the tip of a needle relative to a specific anatomical structure. The elastic bands on the Patient Drape are intended to stabilize the positioning of the Accuro® 3S Needle Guide. The Accuro® 3S Probe Cover sheathes the transducer and isolates a needle insertion site from microbial and other contaminants.

Source page: https://510kreport.com/device/K250469
Methodology: https://510kreport.com/methodology