Class Class II
PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474)
Description
PRIMUS Healthcare Sterilizer (Model PSS11-HC) by Primus Sterilizer Company, LLC, an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221474
Clearance Date2023-02-10
Clearance TypeAbbreviated
Product CodeFLE
Regulation Number880.6880
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221474
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. PRIMUS Healthcare Sterilizer (Model PSS11-HC) (K221474) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K111223 | AMSCO CHIMERON SMALL STEAM STERILIZER | STERIS Corporation | 2011 |
| K093333 | PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL ... | Primus Sterilizer Company, LLC | 2010 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | Primus Sterilizer Company, LLC | 2023 |
Trace the full predicate network for K221474
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.