Dual Incu I
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Dual Incu i EUDAMED
- Model / Reference
- Dual Incu i w/O2 Controller Unit,Dual Incu i w/o O2 Controller Unit EUDAMED61601,61603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04942962616010 EUDAMED
- Basic UDI-DI
- B-04942962616010 EUDAMED
- 510(k) Number
- K102226 FDA 510(k)
- FDA Product Code
- FMZ FDA 510(k)
- EMDN Code
- Z1208040301 FIXED NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5400 FDA 510(k)
- Regulation Number
- 880.5400 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Dual Incu I is a neonatal incubator designed for the care of newborn infants, providing controlled thermal, humidity, and oxygen environments. Classified as a neonatal incubator, it supports critical functions such as temperature regulation, oxygen delivery, and access for medical personnel while maintaining a sterile or clean environment for vulnerable patients.
This device is intended for use in general hospital settings, offering a combination of incubator and infant warmer capabilities for flexible patient care. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDD regulatory standards. The Dual Incu I is available in a single model configuration, with no specified sterility requirements beyond standard hospital protocols, and is not MRI-compatible. Storage and maintenance follow manufacturer guidelines for reusable medical equipment.
Frequently asked questions
Is the Dual Incu I designed for single-use or reusable applications in a hospital setting?
The Dual Incu I is supplied as a reusable medical device, meaning it is intended for repeated use in clinical environments after proper cleaning, maintenance, and sterilization following standard hospital protocols. This aligns with its classification as a reusable neonatal incubator.
What regulatory pathways has the Dual Incu I followed for market authorization, and where is it primarily intended for use?
The Dual Incu I has been authorized through the FDA’s 510(k) pathway and complies with the Medical Device Directive (MDD). It is classified as substantially equivalent to a predicate device and is intended for use in general hospital settings, as indicated by its advisory committee designation (HO) and product code (FMZ).
Does the Dual Incu I come in multiple sizes or models, or is it available in a single configuration?
The Dual Incu I is available in a single model configuration, meaning there are no variations in size or additional variants to choose from. This simplifies inventory management for hospitals while maintaining its core functions for neonatal care.
What environmental controls does the Dual Incu I provide, and how does it support medical personnel access?
The Dual Incu I is designed to regulate temperature, humidity, and oxygen levels for newborn infants, creating a controlled environment critical for their care. It also includes features that allow medical personnel to access the patient while maintaining the sterile or clean environment inside the incubator.
Are there any special storage or maintenance requirements for the Dual Incu I beyond standard hospital protocols?
The Dual Incu I requires adherence to manufacturer guidelines for storage and maintenance, typical of reusable medical equipment. While no specific sterility requirements beyond standard hospital protocols are mentioned, proper cleaning, inspection, and upkeep are essential to ensure its continued safe and effective operation in neonatal care settings.
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: Incubator Dual Incu i | ATOM MEDICAL, ATOM Medical USA | Model 100 Dual Incu i Combination Incubator, Incubator Incu i | ATOM MEDICAL - atomed-global.com, ATOM Medical USA | Atom Products
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K102226 | Class II | Active |
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Manufacturer
- Manufacturer
- Atom Medical Corporation
Sources (3)
- FDA 510(k) K102226 24 fields · synced Sep 18, 2026
- EUDAMED 736fd7a1-b816-43e1-8026-6930e6cabb2a-1 61 fields · synced Jul 20, 2026
- EUDAMED 736fd7a1-b816-43e1-8026-6930e6cabb2a-2 61 fields · synced Jul 20, 2026