STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (K223015)
Description
STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette by Plasmapp Co,., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223015
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. STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (K223015) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | 2021 |
Trace the full predicate network for K223015
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.