# K082817: Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-M

- Pathway: 510(k) (Traditional)
- Applicant: Primus Sterilizer Company, LLC
- Decided: May 21, 2009 after 238 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: 1 generation back to K991575 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K991575: Primus Steam Sterilizers, Primus Sterilizer Co., Inc. (1999) Summary page 1.

## Most influential descendants
- 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 PSS5 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS5 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSS5 Steam Sterilizer Series are available in the following configurations: PSS5-G.1-M*** (32" x 36" x 48" Multi-Functional Sterilizer) Single or PSS5-G.1-L*** (32" x 36" x 48" Laboratory/Lo) Double Door PSS5-M-M*** (35" x 57" x 60" Multi-Function Sterilizer) Single or PSS5-M-L*** (35" x 57" x 60" Laboratory/Lo) Double Door Sterilizers are available both in multi-functional models which feature vacuum, gravity, liquids and test (VAC) cycles and Laboratory/Lo-Temperature Models. The Laboratory/Low Temperature models feature a cycle for pasteurization and inspissation processes of items such as infant formula and other liquids requiring lower temperature sterilization. PRIMUS Sterilizer Company, LLC directions for use cautions this OPTION IS NOT RECOMMENDED FOR REPROCESSING ITEMS FOR DIRECT PATIENT CONTACT. PRIJUS Sterilizer Company, LLC recommends that a suitable chemical indicator or biological challenge test be used on a periodic basis to test effectiveness of the sterilizer in accordance with health care facilities documented plan for monitoring SAL 106 performance. The intended use for the sterilizers models listed above is to provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials, wrapped and unwrapped surgical instruments, hard goods, and linens. The cycles to be cleared for each of the models listed above are found in the table below:

Source page: https://510kreport.com/device/K082817
Methodology: https://510kreport.com/methodology