# K240146: BD Prevue™ II Peripheral Vascular Access System

- Pathway: 510(k) (Special)
- Applicant: Bard Access Systems, Inc.
- Decided: Feb 18, 2024 after 30 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: 11 generations back to K945773 (1995). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211193: BD Prevue II Peripheral Vascular Vascular Access System, Bard Access Systems, Inc. (C.R. Bard, Inc.) (2021) Summary page 5.

## Indications for use
BD Prevue™ II Peripheral Vascular Access System is indicated for Vascular and Vascular Access Imaging Applications performed by appropriately trained healthcare professionals in a medical setting. Typical examinations performed using the BD Prevue™ II Peripheral Vascular Access System include: Imaging Applications: Vascular [Exam Type (Adult and Pediatric)]: 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 [Exam Type (Adult and Pediatric)]: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access in adult and pediatric patients, including those patients with difficult intravascular access who may have small, fragile, and/or non-palpable vessels.

Source page: https://510kreport.com/device/K240146
Methodology: https://510kreport.com/methodology