# K261014: Accuro® 3S Needle Guide Kit

- Pathway: 510(k) (Traditional)
- Applicant: Rivanna Medical, Inc.
- Decided: Jul 24, 2026 after 119 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: 5 generations back to K844472 (1985). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250469: Accuro® 3S Needle Guide Kit, Rivanna Medical, Inc. (2025) Summary page 5.

## Indications for use
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. The SafeTrack™ magnet is detected by magnetic sensors to provide visual guidance for tracking the position of a needle with respect to ultrasound image data.

Source page: https://510kreport.com/device/K261014
Methodology: https://510kreport.com/methodology