Spectra S1Plus and Spectra S2 Plus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150476 FDA 510(k)
- FDA Product Code
- HGX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5160 FDA 510(k)
- Regulation Number
- 884.5160 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Spectra S1 Plus and Spectra S2 Plus are Powered Breast Pumps, classified as Class II medical devices. These devices are designed to assist in the mechanical expression of breast milk, providing a non-invasive method for lactating individuals to collect milk for infant feeding. They incorporate electric motor-driven mechanisms to simulate natural nursing rhythms, enhancing comfort and efficiency during use.
These pumps are intended for home or clinical use and are supplied as reusable devices. They are not sterile upon delivery and must be cleaned and disinfected according to manufacturer guidelines before each use. The devices are MRI-safe as per their design specifications and are available in two models, differentiated by their performance capabilities. Authorised under FDA 510K and MDR, they comply with regulatory standards for obstetrics/gynecology applications.
Frequently asked questions
Are the Spectra S1 Plus and Spectra S2 Plus pumps designed for single-use or reusable applications, and what cleaning requirements apply?
The Spectra S1 Plus and Spectra S2 Plus are reusable devices intended for both home and clinical use. Since they are not sterile upon delivery, they must be cleaned and disinfected according to manufacturer guidelines before each use to ensure hygiene and safety. This process is essential to maintain functionality and prevent contamination.
What distinguishes the Spectra S1 Plus from the Spectra S2 Plus in terms of performance?
The Spectra S1 Plus and Spectra S2 Plus differ primarily by their performance capabilities, though the exact specifications (e.g., suction strength, speed settings, or efficiency) are not detailed in the provided data. The distinction is likely based on engineering or clinical performance metrics, such as milk extraction efficiency or user comfort, but the data does not specify these differences.
Can these pumps be used safely in an MRI environment, and how should they be stored?
Yes, the Spectra S1 Plus and Spectra S2 Plus are MRI-safe as per their design specifications, meaning they can be used in MRI environments without interference. For storage, the manufacturer’s guidelines should be followed, though the data does not specify exact storage conditions (e.g., temperature, humidity). Proper care—such as avoiding moisture or physical damage—is recommended to maintain functionality.
What regulatory pathways have these devices undergone, and which medical specialty do they support?
The Spectra S1 Plus and Spectra S2 Plus are authorized under FDA 510K (Traditional pathway, Substantially Equivalent) and the EU MDR (Medical Device Regulation). They are classified under the Obstetrics/Gynecology medical specialty, reflecting their intended use for lactating individuals to mechanically express breast milk for infant feeding.
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: Spectra S1 Plus / S2 Plus User Manual, Spectra S1 Plus / S2 Plus Instructions - Manuals+, SPECTRABABY - Uzinmedicare, SPECTRABABY - Uzinmedicare
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 | K150476 | Class II | Active |
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Manufacturer
- Manufacturer
- Uzinmedicare Co., Ltd.
- FDA Applicant
- Uzinmedicare Co.
Sources (2)
- FDA 510(k) K150476 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026