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Primus PSS Series Sterilizers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K926185

by Primus Sterilizer Company, LLC

Identifiers

510(k) Number
K926185 FDA 510(k)
FDA Product Code
FLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6880 FDA 510(k)
Regulation Number
880.6880 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Primus PSS Series Sterilizers are Steam Sterilizers designed for healthcare settings to process medical instruments and devices using steam sterilization. These devices employ high-temperature steam to achieve sterilization, ensuring compliance with rigorous infection control standards for reusable medical equipment.

These sterilizers are supplied as reusable medical devices, intended for use in general hospital environments. They are classified as Class II devices under FDA regulations and have received FDA 510K clearance as substantially equivalent to predicate devices. Multiple model variants are available, each with distinct specifications and capacities, and they require proper maintenance and storage to ensure continued performance and sterility.

Frequently asked questions

Are the Primus PSS Series Sterilizers designed for single-use or reusable medical instruments, and how does this affect their maintenance requirements?

The Primus PSS Series Sterilizers are reusable medical devices intended for processing reusable medical instruments and devices. Since they are not single-use, they require regular maintenance to ensure proper function, sterility, and compliance with infection control standards. The manufacturer emphasizes that proper upkeep is essential to maintain performance and reliability over time.

What types of healthcare environments are these sterilizers approved for, and do they have specific capacity or model variations?

The Primus PSS Series Sterilizers are approved for general hospital environments and come in multiple model variants, each with distinct specifications and capacities. While the exact sizes or load capacities aren’t detailed here, the variety suggests they cater to different facility needs—whether small clinics or larger hospitals—while adhering to FDA 510K clearance for steam sterilization in reusable medical settings.

How are these sterilizers regulated, and what does the FDA’s 510K clearance indicate about their safety and equivalence?

The Primus PSS Series Sterilizers received FDA 510K clearance under a Traditional review pathway, meaning they were determined to be substantially equivalent to a predicate device already on the market. This clearance indicates that the sterilizers meet FDA safety and performance requirements for steam sterilization in healthcare settings, though it does not imply approval for specific clinical uses—only that they comply with regulatory standards for reusable medical device sterilization.

Do these sterilizers require any special storage conditions to maintain their effectiveness and sterility?

While the data doesn’t specify exact storage conditions, as reusable medical devices, the Primus PSS Series Sterilizers likely require clean, dry, and protected environments to prevent contamination or damage. Proper storage is critical to ensure the sterilizer’s components remain functional and hygienic for repeated use, aligning with infection control protocols in healthcare facilities.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PRIMUS brand PSS11 Series Healthcare Steam Sterilizers: High ..., PRIMUS Brand Healthcare Steam Sterilizers - spire-is.com, Chalmers Group of Companies - Primus Sterilizer Company

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Primus Sterilizer Company, LLC
FDA Applicant
Primus Sterilizer Co., Inc.

Sources (1)

  • FDA 510(k) K926185 24 fields · synced Sep 19, 2026