Medikro Nano, Medikro Primo And Medikro Pro
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Medikro Oy
Identity
- Trade Name
- Medikro Primo EUDAMEDM914, Medikro® Primo FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- Medikro Primo EUDAMED
- Model / Reference
- M9492 EUDAMEDFDA UDIM914 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06420099000851 EUDAMEDFDA UDI
- Basic UDI-DI
- 6420099M9492LL EUDAMED
- Direct Marketing DI
- 06420099000851 EUDAMED
- 510(k) Number
- K133428 FDA 510(k)
- FDA Product Code
- BZG FDA 510(k)FDA UDI
- EMDN Code
- Z12150101 CLINICAL/DIAGNOSTIC SPIROMETERS EUDAMED
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.1840 FDA 510(k)
- Regulation Number
- 868.1840 FDA 510(k)FDA UDI
- Market of Registration
- Finland EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Medikro Nano, Primo, and Pro are portable and PC-based spirometers designed for diagnostic assessment of pulmonary function. These devices measure lung volume, airflow, and spirometric parameters to evaluate respiratory health, supporting clinical decisions in primary care and specialized settings. They adhere to the classification of a diagnostic spirometer, providing accurate and reproducible results for monitoring conditions such as asthma, chronic obstructive pulmonary disease (COPD), and other respiratory disorders.
The Medikro series is supplied as a reusable system with disposable flow transducers to ensure patient safety and infection control. Each model operates in clinical environments, including offices and mobile settings, and is compatible with MRI-safe conditions as per regulatory standards. The devices are authorized under FDA 510(k), MDD, and MDR frameworks, with Class II designation. They require proper calibration, storage in a clean and dry environment, and adherence to manufacturer guidelines for optimal performance and longevity.
Frequently asked questions
What types of respiratory conditions can the Medikro series help monitor, and how does it support clinical decisions?
The Medikro Nano, Primo, and Pro spirometers are designed to measure lung volume, airflow, and key spirometric parameters to evaluate respiratory health. They are particularly useful for monitoring conditions like asthma, chronic obstructive pulmonary disease (COPD), and other respiratory disorders. By providing accurate and reproducible results, these devices assist clinicians in making informed decisions for diagnosis, treatment planning, and ongoing management in both primary care and specialized settings.
Are the Medikro devices portable, and how do they differ in terms of use between clinical and mobile settings?
Yes, the Medikro series is explicitly designed as portable and can also operate as PC-based spirometers. They are suitable for use in clinical offices as well as mobile settings, such as home visits or field assessments. The devices maintain consistent functionality across these environments, ensuring flexibility for healthcare providers while adhering to regulatory standards for accuracy and reliability.
How are infection control and patient safety ensured with the Medikro spirometers?
The Medikro series is supplied as a reusable system but incorporates disposable flow transducers to minimize cross-contamination risks. This design ensures patient safety and infection control by allowing for easy replacement of components that come into direct contact with patients, reducing the need for full device sterilization between uses.
What storage and maintenance requirements should be followed to maintain the performance and longevity of the Medikro devices?
The Medikro spirometers require storage in a clean and dry environment to prevent damage or degradation. Proper calibration is also essential for maintaining accuracy, and adherence to the manufacturer’s guidelines ensures optimal performance and longevity. Regular maintenance, as specified by Medikro Oy, will help sustain the device’s reliability over time.
Are the Medikro devices compatible with MRI environments, and how does this affect their use in clinical settings?
Yes, the Medikro series is designed to be MRI-safe, meaning it can be used in clinical environments where MRI procedures are performed without interference or safety risks. This compatibility expands their utility in hospitals and specialized centers where both respiratory assessments and MRI scans may be conducted, ensuring seamless integration into multi-modal diagnostic workflows.
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: Medikro Primo | Durable Office Spirometer | M914, Spirometer User Manual (All models) - Medikro, Medikro Spirometer - Team Medical, Medikro | Nano Portable Spirometry - Bird Healthcare
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K133428 | Class II | Active |
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Manufacturer
- Manufacturer
- Medikro Oy
Sources (3)
- FDA 510(k) K133428 24 fields · synced Oct 6, 2026
- FDA UDI cb044e7e-a99f-43f9-b6c7-8e80f35a437b 32 fields · synced May 30, 2026
- EUDAMED f94242c0-b241-4735-a8a6-e1bd8ca1a93a 61 fields · synced Jul 14, 2026