BETA
U.S. manufacturer of steam sterilizers and autoclaves for healthcare and laboratory facilities.
Consolidated Sterilizer Systems manufactures configurable steam sterilizers for healthcare and laboratory applications. The business operates from Billerica, Massachusetts, with equipment and services spanning hospitals, ambulatory surgery centers and life-science facilities.
The Consolidated HC Steam Sterilizer has a device-specific FDA 510(k) clearance. Laboratory equipment and healthcare sterilizers serve different use cases, so the profile does not treat every laboratory model as covered by that medical-device authorization.
CEO Renaud Maloberti joined in August 2025. Manufacturing, equipment configuration, installation support and ongoing service shape the commercial model, with sales supported by manufacturer representatives and distributors. The company also offers water-treatment and validation services around sterilization workflows.
The HC Steam Sterilizer has a matched 510(k) clearance. FDA also records an older SR/SSE MC-series decision under Consolidated Machine Corp.; that history does not establish that every laboratory autoclave is cleared for healthcare use. [9][10][2][3][4][5][13]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [15][16]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Steam sterilizer for compatible medical products and healthcare loads. [10][1]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Configurable steam sterilizers for research and laboratory applications; model-specific medical-device status not established. [9]
Marketed · regulatory scope variesCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial healthcare and laboratory equipment; clearance applies to the named HC system, not every lab model. [9][10]
FDA issued a substantially equivalent decision for Consolidated HC Steam Sterilizer. [1]
Accessed 10/20/2026