Spectra Wearable Breast Pump
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220926 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 Wearable Breast Pump is a Powered, Breast Pump (Class II device) designed for breast milk expression. It is intended to assist lactating individuals in manually or electrically powered milk extraction, supporting breastfeeding practices in clinical and home settings.
This device is supplied as a reusable system, with components that may require cleaning and maintenance. It is not classified as MRI-safe or sterile upon packaging, and its use is regulated under FDA 510(k) clearance (K220926) and the EU Medical Device Regulation (MDR). Multiple registration numbers (e.g., 3012298445) reflect its compliance with obstetrics/gynecology specialty standards.
Frequently asked questions
Is the Spectra Wearable Breast Pump designed for single-use or can it be reused over time?
The Spectra Wearable Breast Pump is supplied as a reusable system, meaning it is intended for repeated use by the same user. Since it is not classified as sterile upon packaging, proper cleaning and maintenance are required between uses to ensure hygiene and functionality.
What settings or variations of the Spectra Wearable Breast Pump are available, and how do they differ?
The Spectra Wearable Breast Pump is available in multiple registration numbers (e.g., 3012298445, 3024790242, etc.), which likely correspond to different models or variations. While the exact specifications of each model are not detailed here, these variations may include differences in features, performance settings, or compatibility with accessories. For precise details, refer to the manufacturer’s documentation or contact Uzinmedicare Co., Ltd.
Can the Spectra Wearable Breast Pump be used safely in an MRI environment, and if not, what alternatives should be considered?
The Spectra Wearable Breast Pump is explicitly not classified as MRI-safe. If MRI imaging is required for the user, alternative breast pumping methods or devices should be used during the scan to avoid potential risks associated with exposure to magnetic fields.
How should the Spectra Wearable Breast Pump be stored to maintain its performance and longevity?
Since the device is reusable and not sterile, it should be stored in a clean, dry environment when not in use. Follow the manufacturer’s guidelines for disassembly, cleaning, and maintenance to prevent damage or contamination. Avoid exposure to extreme temperatures or direct sunlight, which could degrade materials or affect functionality.
What regulatory pathways does the Spectra Wearable Breast Pump follow, and how does this affect its availability?
The Spectra Wearable Breast Pump has undergone FDA 510(k) clearance (K220926) and complies with the EU Medical Device Regulation (MDR). This means it has met the necessary regulatory standards for marketing and distribution in the U.S. and EU markets, respectively. Availability may vary by region based on these approvals, so check local regulations or the manufacturer’s documentation for specific guidance.
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: SPECTRABABY - Uzinmedicare, SPECTRABABY - Uzinmedicare, PDF April 6, 2026 Uzinmedicare Co., Ltd. ℅ Jong CEO Trade/Device Name ..., Uzinmedicare Co., Ltd. FDA 510 (k) Products - Latest 2026, K220926 FDA 510(k) - Spectra Wearable | Uzinmedicare Co., Ltd.
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 | K220926 | Class II | Active |
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Manufacturer
- Manufacturer
- Uzinmedicare Co., Ltd.
Sources (2)
- FDA 510(k) K220926 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026