BL Healthcare Remote Care Management System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101078 FDA 510(k)
- FDA Product Code
- DRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2910 FDA 510(k)
- Regulation Number
- 870.2910 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BL Healthcare Remote Care Management System is a Transmitter and Receiver, Physiological Signal, Radiofrequency device designed to facilitate remote monitoring of cardiovascular patients. It enables wireless transmission of physiological data, including vital signs, between patient-worn sensors and healthcare facility servers for continuous care management.
This system is intended for use in cardiac care settings, transmitting real-time data such as weight, blood pressure, pulse rate, and blood glucose to authorized healthcare providers. Supplied as a non-sterile, reusable solution, it operates under FDA 510(k) clearance (K101078) and adheres to Class II regulatory standards (870.2910). Compatible with multiple physiological monitoring devices, it requires proper storage and maintenance as specified in the manufacturer’s instructions.
Frequently asked questions
What types of physiological data can the BL Healthcare Remote Care Management System transmit, and how is this useful in cardiac care settings?
The system wirelessly transmits real-time physiological data such as weight, blood pressure, pulse rate, and blood glucose levels from patient-worn sensors to healthcare providers. This continuous monitoring is particularly valuable in cardiac care settings as it allows for proactive management of patients with cardiovascular conditions, enabling timely interventions based on trends or abnormalities in these vital signs.
Is the BL Healthcare Remote Care Management System designed for single-use or reusable applications, and how does this affect maintenance?
The system is supplied as a non-sterile, reusable solution. This means it requires proper cleaning, maintenance, and storage as outlined in the manufacturer’s instructions to ensure reliable performance and longevity. Reusability also reduces waste, but it necessitates adherence to protocols to prevent cross-contamination or signal interference.
What regulatory pathway was followed for FDA clearance of the BL Healthcare Remote Care Management System, and what does this imply for its use?
The system received FDA clearance through a 510(k) pathway, specifically under K101078, with a substantially equivalent determination and a special clearance type. This implies the device was deemed comparable to a legally marketed predicate device and adheres to Class II regulatory standards (870.2910). Clinically, this means it has undergone FDA review for safety and effectiveness in its intended use for remote monitoring of cardiovascular patients.
How does the system’s compatibility with other devices impact its practical application in a clinical environment?
The BL Healthcare Remote Care Management System is designed to be compatible with multiple physiological monitoring devices, allowing it to integrate seamlessly into existing workflows. This flexibility ensures that healthcare providers can leverage their current sensors and infrastructure while benefiting from the system’s wireless transmission capabilities. It reduces the need for additional hardware and streamlines remote patient monitoring across various cardiac care settings.
What storage requirements should be followed to ensure the system remains functional and reliable?
While the device data does not specify exact storage conditions, reusable medical devices like this typically require protection from environmental factors such as extreme temperatures, humidity, and physical damage. The manufacturer’s instructions (not detailed here) should be followed to maintain calibration, signal integrity, and longevity. Proper storage also helps prevent interference or degradation of the radiofrequency components critical to its wireless functionality.
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: BL Healthcare, REMOTE CARE MANAGEMENT SYSTEMS (RCMS) by BL HEALTHCARE, INC. | FDA 510 ..., Services - BL Healthcare, BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (K101078) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101078 | Class II | Active |
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Manufacturer
- Manufacturer
- Bl Healthcare, Inc.
Sources (1)
- FDA 510(k) K101078 24 fields · synced Sep 19, 2026