Gambro Fluid Control Monitor FCM 10-1
FDA 510(k)Class II (US FDA 510(k))
by Gambro, Inc.
Identifiers
- 510(k) Number
- K864094 FDA 510(k)
- FDA Product Code
- FKP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gambro Fluid Control Monitor FCM 10-1 is a System, Dialysate Delivery, Single Patient, classified under product code FKP. This device is designed to control and monitor the flow of dialysate within the dialysate compartment of a dialyzer, ensuring precise regulation of fluid dynamics during dialysis procedures. It incorporates pressure monitoring, alarms, and safety features to maintain the integrity of the extracorporeal blood circuit.
The FCM 10-1 is intended for use in clinical settings such as dialysis centers, where it operates as a standalone or integrated component of a larger hemodialysis system. Supplied as a reusable device, it requires proper sterilization and maintenance per manufacturer guidelines. The device adheres to FDA 510(k) clearance (K864094) under Class II regulatory classification, with no explicit MRI safety or single-use designation noted in the specifications. Storage and handling must comply with Gambro’s established protocols to ensure operational reliability.
Frequently asked questions
Is the Gambro Fluid Control Monitor FCM 10-1 designed for single-use or can it be reused after proper sterilization and maintenance?
The FCM 10-1 is explicitly labeled as a reusable device in the provided data. It requires sterilization and maintenance following Gambro’s guidelines to ensure safe and reliable operation during dialysis procedures. Unlike single-use devices, this model is intended for repeated use in clinical settings like dialysis centers, provided it is properly cleaned and maintained.
What specific clinical environments or procedures is the FCM 10-1 intended to support, and how does it function within those settings?
The FCM 10-1 is designed for use in dialysis centers as part of hemodialysis systems. It controls and monitors dialysate flow within the dialyzer’s dialysate compartment, ensuring precise fluid regulation during dialysis. The device includes pressure monitoring and alarms to safeguard the extracorporeal blood circuit, making it a critical component for maintaining treatment integrity in hemodialysis procedures.
How is the FCM 10-1 regulated, and what does its FDA clearance status indicate about its safety and performance?
The FCM 10-1 holds FDA 510(k) clearance (K864094) under Class II regulatory classification, with a decision of *Substantially Equivalent* to a predicate device. This clearance indicates that the FDA has determined the device meets applicable safety and performance standards for its intended use in dialysate delivery systems. The classification as Class II means it is subject to general controls and special controls specific to its category, ensuring ongoing compliance with regulatory requirements.
What safety features does the FCM 10-1 include to protect patients during dialysis, and how do these features contribute to treatment reliability?
The FCM 10-1 incorporates pressure monitoring and alarm systems to maintain the integrity of the extracorporeal blood circuit during dialysis. These features help detect deviations in dialysate flow or pressure, allowing for immediate intervention to prevent complications. By ensuring precise fluid dynamics, the device supports safer and more reliable hemodialysis treatments, reducing risks associated with improper dialysate regulation.
Are there any specific storage or handling requirements for the FCM 10-1 to ensure it remains operational and safe for use?
The FCM 10-1 must be stored and handled according to Gambro’s established protocols to maintain operational reliability. While the data does not specify exact storage conditions (e.g., temperature or humidity), adherence to manufacturer guidelines—including proper cleaning, sterilization, and maintenance—is critical for ensuring the device functions correctly and safely in clinical settings. Failure to follow these protocols could compromise performance or patient safety.
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: K864094 - GAMBRO FLUID CONTROL MONITOR FCM 10-1 | FDA 510 (k), GAMBRO FLUID CONTROL MONITOR FCM 10-1 - Innolitics, PDF K864094 - Gambro Fluid Control Monitor Fcm 10-1, 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 | K864094 | Class II | Active |
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Manufacturer
- Manufacturer
- Gambro, Inc.
Sources (1)
- FDA 510(k) K864094 24 fields · synced Oct 6, 2026