# K262474: ND Needle Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Accurate Access, LLC
- Decided: Jul 27, 2026 after 10 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: 6 generations back to K850478 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160806: Verza Guidance System, CIVCO Medical Instruments Co., Inc. (2016) Summary page 5.
- K093713: Ultrasound General Purpose Guidance System, Civco Medical Instruments (2010) Summary page 5.

## Indications for use
The ND® Needle Guidance System is indicated for use in ultrasound-guided procedures where precise placement of common interventional devices is required, such as for vascular access.

Source page: https://510kreport.com/device/K262474
Methodology: https://510kreport.com/methodology