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Blood Monitor BMM 10-4

FDA 510(k)

Class II (US FDA 510(k))

510(k) K831404

by Gambro, Inc.

Identifiers

510(k) Number
K831404 FDA 510(k)
FDA Product Code
LLB 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 Blood Monitor BMM 10-4 is an extracorporeal blood monitoring system designed for use in blood processing applications. Classified under the FDA product code LLB as a System, Blood, Extracorporeal and Accessories, it is intended for monitoring blood during extracorporeal procedures, such as dialysis or blood purification therapies. This device supports critical functions in maintaining patient safety by ensuring proper blood flow and quality during treatment.

The Blood Monitor BMM 10-4 is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K831404), granted in 1984. It is intended for use in clinical settings such as gastroenterology and urology, where precise monitoring of blood parameters is essential. The device adheres to FDA Class II regulatory standards and is part of extracorporeal blood processing systems. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What is the Blood Monitor BMM 10-4 used for?

The Blood Monitor BMM 10-4 is designed for monitoring blood during extracorporeal procedures, such as dialysis or blood purification therapies. It helps maintain patient safety by ensuring proper blood flow and quality throughout treatment, making it essential in clinical settings like gastroenterology and urology.

Is the Blood Monitor BMM 10-4 reusable or single-use?

The Blood Monitor BMM 10-4 is supplied as a reusable medical device. This classification allows for multiple uses after proper cleaning and maintenance, reducing waste and cost over time while adhering to FDA regulatory standards for reusable extracorporeal systems.

What regulatory approval does the Blood Monitor BMM 10-4 hold?

The Blood Monitor BMM 10-4 holds FDA 510(k) clearance under the reference number K831404, granted in 1984. It is classified under FDA product code LLB as a System, Blood, Extracorporeal and Accessories, and is regulated under FDA Class II standards.

In which clinical specialties is the Blood Monitor BMM 10-4 primarily used?

This device is primarily intended for use in gastroenterology and urology. Its precise monitoring capabilities are particularly valuable in procedures where maintaining blood quality and flow is critical, such as during dialysis or blood purification therapies.

Does the Blood Monitor BMM 10-4 include any specific sterility or MRI safety information?

The available data for the Blood Monitor BMM 10-4 does not provide explicit details regarding sterility or MRI safety. Clinicians should follow standard protocols for cleaning, maintenance, and usage to ensure safe operation, particularly in environments where MRI compatibility may be a concern.

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: BLOOD MONITOR BMM 10-4 (K831404) — FDA 510 (k) | Innolitics, K831404 - BLOOD MONITOR BMM 10-4 | FDA 510(k) | Gambro, Inc., BLOOD MONITOR BMM 10-4 510 (k) K831404 - FDA.report, FDA Product Code LLB - System, Blood, Extracorporeal And Accessories, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gambro, Inc.

Sources (1)

  • FDA 510(k) K831404 24 fields · synced Oct 1, 2026