# K093333: Primus Steam Sterilizer PSS8-AA (16X16X26 Multi Functional Sterilizer), Lab/LO Sterilizer,Primus Steam Sterilizer PSS8

- Pathway: 510(k) (Abbreviated)
- Applicant: Primus Sterilizer Company, LLC
- Decided: Apr 2, 2010 after 158 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: 2 generations back to K991575 (1999). 2 ancestors in all.
2 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.
- K082817: Primus Steam Sterilizer, Models PSS5-G-1 and PSS5-M, Primus Sterilizer Company, LLC (2009) Summary page 1.

## Most influential descendants
- 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 PSS8 Steam Sterilizer Series are designed for use in the Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS8 Steam Sterilizer Series provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PRIMUS PSS8 Steam Sterilizer Series are available in the following configurations: Sterilizers are available in multi-functional models which feature vacuum, gravity, liquids and test (VAC) cycles. PRIMUS 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 10~ 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/K093333
Methodology: https://510kreport.com/methodology