Identifiers
- 510(k) Number
- K251851 FDA 510(k)
- FDA Product Code
- FIP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5665 FDA 510(k)
- Regulation Number
- 876.5665 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DIASAFEplusUS (F00013010) is a Subsystem for Water Purification, designed to ensure the quality and safety of water used in medical and dialysis applications. It is classified as a Class 2 device under FDA regulation 876.5665, intended for use in environments requiring high-purity water, such as hemodialysis or other renal therapies. The system is engineered to remove contaminants, including bacteria, endotoxins, and particulate matter, to meet stringent medical standards. Its purpose aligns with regulatory categories for Gastroenterology and Urology, though its primary function remains water purification for medical subsystems.
This device is supplied as a reusable subsystem, intended for integration into larger medical systems such as dialysis machines. It operates within controlled environments like hospitals, dialysis centers, or clinical laboratories where water purity is critical. The DIASAFEplusUS (F00013010) has received FDA 510(k) clearance (K251851) under the Traditional pathway, demonstrating compliance with regulatory requirements for water purification systems. Storage and maintenance protocols are manufacturer-specific, though the device is not classified as single-use or MRI-compatible. Its regulatory filing reflects a Substantially Equivalent (SESE) determination, ensuring it meets existing performance standards for similar subsystems.
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: DIASAFEplusUS (F00013010) (K251851) — FDA 510(k) | Innolitics, K251851 FDA 510 (k) - DIASAFEplusUS (F00013010), DIASAFEplusUS (F00013010) 510 (k) K251851 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251851 | Class II | Active |
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Manufacturer
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
Sources (1)
- FDA 510(k) K251851 24 fields · synced Sep 20, 2026