# K221474: PRIMUS Healthcare Sterilizer (Model PSS11-HC)

- Pathway: 510(k) (Abbreviated)
- Applicant: Primus Sterilizer Company, LLC
- Decided: Feb 10, 2023 after 266 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K820783 (1982). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093333: Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO Sterilizer,Primus Steam Sterilizer PSS8, Primus Sterilizer Company, LLC (2010) Summary page 7.
- K111223: Amsco Chimeron Small Steam Sterilizer, STERIS Corporation (2011) Summary page 7.

## Most influential descendants
- K233132: PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (2023), 0 descendants of its own

## Indications for use
The PRIMUS Healthcare Sterilizer (Model PSS11-HC) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer. A table describing the Cycle, Exp. temp., Exp. time, Dry time, Recommended load, and maximum items per chamber size is available on the next page.

Source page: https://510kreport.com/device/K221474
Methodology: https://510kreport.com/methodology