Class Class II
Transducer Probe Cover (K221278)
Description
Transducer Probe Cover by Hony Medical Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221278
Clearance Date2023-01-11
Clearance TypeTraditional
Product CodeITX
Regulation Number892.1570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221278
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Transducer Probe Cover (K221278) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211270 | CIV-Clear cover | CIVCO Medical Instruments Co., Inc. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024 |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024 |
Trace the full predicate network for K221278
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.