Midmark Smart M9 Sterilizer, Midmark Smart M11 Sterilizer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233026 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 Smart M9 Sterilizer and Midmark Smart M11 Sterilizer are steam sterilizers designed for use in general hospital settings. These devices utilize steam to achieve sterilization of medical instruments and supplies, ensuring compliance with infection control protocols for reusable items.
These sterilizers are intended for use in hospital environments and are supplied as reusable medical devices. They are classified as Class II devices under FDA regulations and have received 510(k) clearance. The units are not single-use and require proper maintenance, including water filling and steam cycle validation, to ensure effective sterilization. Storage and operation follow standard hospital instrument processing protocols.
Frequently asked questions
Are these sterilizers designed for use outside of hospital settings, such as clinics or dental offices?
No, the Midmark Smart M9 and Smart M11 sterilizers are explicitly designed for general hospital settings only, as indicated by their classification under the FDA’s General Hospital advisory committee (HO). While steam sterilization principles apply broadly, their regulatory submission and intended use are limited to hospitals, not outpatient or ambulatory care facilities.
How do I know if my facility’s water supply is compatible with these sterilizers, and do I need to replace it?
The Midmark Smart M9 and M11 sterilizers require proper maintenance, including filling with water, but the device data does not specify water quality requirements beyond standard hospital instrument processing protocols. Facilities should ensure their water meets boiler feedwater standards (e.g., low hardness, minimal contaminants) to prevent scale buildup or corrosion. Water replacement frequency depends on usage and local water quality—consult Midmark’s operational manual for specifics.
Can these sterilizers be used for sterilizing single-use items, or are they strictly for reusable medical instruments?
The Midmark Smart M9 and M11 sterilizers are intended exclusively for reusable medical instruments and supplies, per their description. Steam sterilization is not suitable for single-use items (e.g., disposables), which are designed to be used once and discarded. These devices comply with infection control protocols for reprocessing reusable items only.
What distinguishes the Smart M9 from the Smart M11, and which one should I choose for my hospital’s needs?
The device data does not provide technical specifications comparing the Smart M9 and Smart M11 (e.g., chamber size, cycle time, or load capacity). Both are steam sterilizers for general hospital use, but differences likely lie in capacity, automation features, or integration options. To determine the right model, evaluate your hospital’s daily load volume, workflow needs, and consult Midmark’s product brochures or a sales representative for side-by-side comparisons.
How often must these sterilizers undergo maintenance, and is there a recommended schedule for cycle validation?
The Midmark Smart M9 and M11 are reusable devices requiring regular maintenance, including water filling and steam cycle validation to ensure sterilization efficacy. While the data does not specify a fixed schedule, hospitals must follow standard hospital instrument processing protocols, typically mandating daily cycle validation (e.g., using biological indicators) and periodic preventive maintenance (e.g., monthly inspections, annual servicing). Refer to Midmark’s user manual for exact procedures.
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 Medical | M9® Steam Sterilizer, Midmark M9® -05x / M11® -05x Sterilizer, Midmark M9® -05x / M11® -05x Sterilizer Training and Videos, Midmark M11 & M9 | Steam Sterilizers | Autoclaves - Henry Schein, Midmark Next Gen M11 and M9 Steam Sterilizers: Your Trusted ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233026 | Class II | Active |
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Manufacturer
- Manufacturer
- Midmark Corporation
Sources (1)
- FDA 510(k) K233026 24 fields · synced Sep 19, 2026