Gambro Water Purification Monitor WRD
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K811678 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 Gambro Water Purification Monitor WRD is a subsystem for water purification intended for use with a hemodialysis system. It is designed to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate.
This device is supplied as a Class II medical device under FDA 510(k) clearance K811678, with product code FIP. It was cleared by the FDA on July 10, 1981, following a traditional review process, and is classified under regulation number 876.5665 with special controls applicable to gastroenterology and urology applications.
Frequently asked questions
What is the Gambro Water Purification Monitor WRD intended for?
The Gambro Water Purification Monitor WRD is a subsystem designed to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate in hemodialysis systems. It is not a standalone treatment device but a component that supports water purification within a larger hemodialysis setup.
How is the Gambro Water Purification Monitor WRD supplied and what is its regulatory classification?
The device is supplied as a Class II medical device under FDA 510(k) clearance K811678, with product code FIP. It was cleared via a traditional review process on July 10, 1981, and is classified under regulation number 876.5665 for gastroenterology and urology applications. This classification reflects its regulatory pathway, not a clinical indication for patient treatment.
What regulatory pathway was used for the Gambro Water Purification Monitor WRD, and what does that imply about its status?
The device received FDA 510(k) clearance through a traditional review process, meaning it was found substantially equivalent to a legally marketed predicate device. This pathway does not imply approval or endorsement for new indications but confirms it meets safety and effectiveness standards for its intended use as a water purification subsystem in hemodialysis.
What special controls apply to the Gambro Water Purification Monitor WRD based on its classification?
The device is subject to special controls applicable to gastroenterology and urology applications, as indicated by its regulation number 876.5665 and medical specialty description. These controls are tied to its regulatory classification and ensure performance and safety in the context of water purification for dialysis, not direct patient treatment functions.
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: K811678 - GAMBRO WATER PURIFICATION MONITOR WRD | FDA 510(k), FDA Browser - Cleared 510 (K) - GAMBRO WATER PURIFICATION MONITOR WRD ..., PDF K811678 - Gambro Water Purification Monitor Wrd, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K811678 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K811678 24 fields · synced Oct 6, 2026