# K233965: UltraDrape UGPIV Barrier and Securement (34-15)

- Pathway: 510(k) (Traditional)
- Applicant: Parker Laboratories, Inc.
- Decided: Aug 15, 2024 after 244 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: 3 generations back to K844472 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221278: Transducer Probe Cover, Hony Medical Co., Ltd. (2023) Summary page 4.

## Indications for use
UltraDrape UGPIV Barrier and Securement, a sterile, single-use disposable device, serves as a sterile, viral barrier when used in conjunction with ultrasound transducers to shield patients from the potential transfer of contaminants and biological risk agents that may be introduced during ultrasound scanning and needle-guided procedures. It also serves as a transparent dressing to protect and secure devices to the patient’s skin when required. UltraDrape UGPIV Barrier and Securement is indicated for adults and pediatric patients. For use by healthcare professionals appropriately trained in ultrasound within healthcare settings utilizing ultrasound.

Source page: https://510kreport.com/device/K233965
Methodology: https://510kreport.com/methodology