# K233132: PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

- Pathway: 510(k) (Abbreviated)
- Applicant: Primus Sterilizer Company, LLC
- Decided: Dec 19, 2023 after 83 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: 7 generations back to K820783 (1982). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221474: PRIMUS Healthcare Sterilizer (Model PSS11-HC), Primus Sterilizer Company, LLC (2023) Summary page 9.

## Indications for use
The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) 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/K233132
Methodology: https://510kreport.com/methodology