Midmark M9, M11 UltraClave and Ritter M9D AutoClave Automatic Steam Sterilizers
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163337 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 Midmark M9, M11 UltraClave and Ritter M9D AutoClave Automatic Steam Sterilizers are steam sterilizers designed for processing medical and dental instruments. These devices utilize high-pressure steam to achieve effective sterilization, ensuring compliance with infection control standards in healthcare settings. They are categorized as Class II devices under FDA regulations and are intended for use in general hospital environments.
These sterilizers are self-contained units, requiring only water for operation, and are supplied as reusable medical devices. They are not MRI-safe and are regulated under FDA 510(k) clearance and EU MDR compliance. The M9 and M11 models feature a compact footprint for optimized workflow integration, while the M9D variant is designed for automated sterilization cycles. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and longevity.
Frequently asked questions
Are these sterilizers suitable for use in dental offices, or are they only intended for hospitals?
These sterilizers are designed for general hospital environments, as indicated by their classification under FDA’s General Hospital advisory committee (HO). While they can process medical and dental instruments, their primary regulatory route and submission history (FDA 510(k) clearance) reflect their intended use in hospitals. However, their steam sterilization technology and compliance with infection control standards make them adaptable for dental offices as well, provided they meet local regulatory requirements for dental settings.
How are the M9, M11 UltraClave, and M9D AutoClave sterilizers supplied, and are they single-use or reusable?
These sterilizers are supplied as reusable medical devices, meaning they are not disposable. They are self-contained units that require only water for operation and are designed for repeated use in healthcare settings. Maintenance and storage follow manufacturer guidelines to ensure proper functionality and longevity, as noted in the device description.
What distinguishes the M9D AutoClave from the M9 and M11 UltraClave models?
The M9D AutoClave is specifically designed for automated sterilization cycles, which likely streamlines operation compared to the M9 and M11 UltraClave models. While the M9 and M11 are described as compact for optimized workflow integration, the M9D’s automation suggests it may offer additional convenience or efficiency for users, though exact differences in features or performance are not detailed in the provided data.
Can these sterilizers be used in an MRI environment, or are there any safety concerns?
These sterilizers are explicitly noted as not MRI-safe in the device description. This means they should not be placed in or near an MRI scanner, as the presence of metal or electrical components could interfere with MRI imaging or pose safety risks to patients and staff.
What regulatory pathways have these sterilizers undergone, and how does that affect their use?
These devices have undergone FDA 510(k) clearance and comply with EU MDR (Medical Device Regulation). The FDA classification is as Class II devices, and their submission history (e.g., K163337) indicates they were reviewed by the General Hospital (HO) advisory committee. This regulatory route ensures they meet U.S. and EU standards for safety and effectiveness in healthcare settings, but users should confirm compliance with local regulations for their specific country or facility.
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: Midmark M11 & M9 | Steam Sterilizers | Autoclaves - Henry Schein, Midmark M9® Steam Sterilizer, Midmark Dental Steam Sterilizers | Autoclaves for Instrument Processing, PDF 003-2707-99 M9 / M9D / M11Self -Contained Steam Sterilizer - Midmark
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K163337 | Class II | Active |
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Manufacturer
- Manufacturer
- Midmark Corporation
Sources (2)
- FDA 510(k) K163337 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026