# K211193: BD Prevue II Peripheral Vascular Vascular Access System

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.)
- Decided: Jun 25, 2021 after 65 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K945773 (1995). 42 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech, C. R. Bard (2018) Summary page 5.

## Most influential descendants
- K251673: X9 Ultrasound System (2025), 0 descendants of its own
- K240146: BD Prevue™ II Peripheral Vascular Access System (2024), 0 descendants of its own

## Indications for use
The BD Prevue™ II Peripheral Vascular Access System is intended for diagnostic ultrasound imaging of the human body performed by appropriately trained healthcare professionals in a medical setting. Specific clinical applications include: • Pediatric • Peripheral Vessel and Vascular Access Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include: Imaging Applications — Exam Type (Adult and Pediatric) Vascular: Assessment of vessels in the extremities and neck leading to or coming from the heart, superficial veins in the arms and legs, and vessel mapping. Assessment of superficial thoracic vessels. Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access. The Cue™ Needle Tracking System is intended to provide visual needle tracking to assist with ultrasound guided vascular access.

Source page: https://510kreport.com/device/K211193
Methodology: https://510kreport.com/methodology