# K221278: Transducer Probe Cover

- Pathway: 510(k) (Traditional)
- Applicant: Hony Medical Co., Ltd.
- Decided: Jan 11, 2023 after 253 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: 2 generations back to K844472 (1985). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970513: General Purpose Tranducer Cover, CIVCO Medical Instruments Co., Inc. (1997) Summary page 5.

## Most influential descendants
- K233965: UltraDrape UGPIV Barrier and Securement (34-15) (2024), 0 descendants of its own
- K241615: Transducer Probe Cover (2024), 0 descendants of its own

## Indications for use
Transducer Probe Cover placed over diagnostic ultrasound transducer/ probe scan head instruments. The cover allows use of the transducer in scanning and needle guided procedures for external intact skin diagnostic ultrasound, while helping to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer. The cover also provides a means for maintenance of a sterile field. Transducer Probe Cover are furnished sterile; single use patient/procedure, disposable.

Source page: https://510kreport.com/device/K221278
Methodology: https://510kreport.com/methodology