# K991575: Primus Steam Sterilizers

- Pathway: 510(k) (Abbreviated)
- Applicant: Primus Sterilizer Co., Inc.
- Decided: Dec 3, 1999 after 211 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K082817: Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-M (2009), 3 descendants of its own
- K093333: Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO Sterilizer,Primus Steam Sterilizer PSS8 (2010), 2 descendants of its own
- K221474: PRIMUS Healthcare Sterilizer (Model PSS11-HC) (2023), 1 descendant of its own
- K233132: PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (2023), 0 descendants of its own

## Indications for use
The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are avallablc in the following configurations: 13” x 13" x 23" Multi-Functional Sterilizer 13" X 13" x 23" Laboratory/Lo 16” x 16" x 26” Multi-Functional Sterilizer 16” x 16” x 26” Laboratory/Lo 20” x 20” x 38" Multi-Functional Sterilizer 20” x 20” x 38” Laboratory/Lo 26” x 26” x 39” Multi-Functional Sterilizer 26” x 26” x 39" Laboratory/Lo 26" x 26” x 49” Multi-Functional Sterilizer 26" x 26" x 49" Laburatory/Lo 26” x 26” x 67” Multi-Functional Sterilizer 26” x 26” x 67” Laboratory/Lo 26" x 36™ x 39" Multi-Functional Sterilizer 26” x 36” x 39” Laboratory/Lo 26" x 36™ x 48" Multi-Functional Sterilizer 26” x 36” x 48" Laboratory/Lo 26" x 36" x 60” Multi-Functional Sterilizer 26 x 36" x 60" Laboratory/Lo 26” x 63” x 48" Multi-Functional Sterilizer 26" x 63" x 48" Laboratory/Lo 26" x 63” x 76" Multi-Functional Sterilizer 26" x 63" x 76" Laboratory/Lo Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the vacuum and gravity cycles as well as a low temperature feature for pasteurization and sterilization processes.

Source page: https://510kreport.com/device/K991575
Methodology: https://510kreport.com/methodology