Consolidated HC Steam Sterilizer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220736 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 Consolidated HC Steam Sterilizer is a steam-based device designed to sterilize autoclavable medical devices. It operates at temperatures between 250° F and 275° F (121° C and 135° C) to ensure the effective processing of equipment.
This device is available in a variety of sizes with stainless steel vessel construction and features both gravity and pre-vacuum operation modes. It is intended for use in healthcare facilities and has received FDA 510(k) clearance.
Frequently asked questions
What is the primary purpose of the Consolidated HC Steam Sterilizer?
This device is intended for use in healthcare facilities to sterilize autoclavable medical equipment using steam-based processing.
What temperature range does this sterilizer operate within?
The unit operates at temperatures between 250° F and 275° F (121° C and 135° C) to ensure the effective processing of medical devices.
What operational modes are available on this device?
The Consolidated HC Steam Sterilizer features both gravity and pre-vacuum operation modes to accommodate different sterilization requirements.
What is the construction material of the sterilizer vessel?
The vessel is constructed from stainless steel, which is designed to provide durability for the sterilization environment.
Has this device received regulatory clearance?
Yes, the Consolidated HC Steam Sterilizer has received FDA 510(k) clearance, as indicated by the provided regulatory documentation.
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: PDF Consolidated HC Steam Sterilizers General Specifications, Steam Sterilizers and Autoclaves for Labs — Made in USA | CSS, K220736 FDA 510 (k) - Consolidated HC Steam Sterilizer, Consolidated HC Steam Sterilizer (K220736) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220736 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Consolidated Machine Corp.
Sources (1)
- FDA 510(k) K220736 24 fields · synced Sep 26, 2026