Telephone Based Bl Healthcare Remote Care Management System (rcms)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052608 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)
This device is a Transmitter and Receiver, Physiological Signal, Radiofrequency (per FDA classification) designed to collect and transmit patient health data via telephone-based communication. It enables remote monitoring of physiological parameters such as weight, blood pressure, and pulse rate, facilitating continuous care management outside traditional clinical settings.
The system is installed by trained professionals and operated by patients for data collection, supporting remote communication between patients and healthcare providers. Supplied as a reusable, non-sterile medical device, it operates within Class II regulatory standards (FDA 510(k) clearance, K052608) and is intended for use in outpatient or home-based care environments. No MRI safety or single-use specifications are indicated in the regulatory data.
Frequently asked questions
How is the BL Healthcare Remote Care Management System (RCMS) intended to be used in clinical settings?
The RCMS is designed for remote monitoring of patients in outpatient or home-based care environments. It collects and transmits physiological data such as weight, blood pressure, and pulse rate via telephone-based communication, enabling continuous care management outside traditional clinical settings. Patients operate the system for data collection, while healthcare providers remotely monitor the information.
Is the BL Healthcare Remote Care Management System (RCMS) a single-use or reusable device, and what does that mean for maintenance?
The RCMS is supplied as a reusable, non-sterile medical device. This means it is intended for repeated use by multiple patients, but it does not require sterilization between uses. Proper cleaning and maintenance procedures must be followed to ensure its safe and effective operation over time.
What regulatory pathway was followed for the FDA clearance of the BL Healthcare Remote Care Management System (RCMS)?
The RCMS received FDA clearance through a 510(k) submission, classified under the Transmitters and Receivers, Physiological Signal, Radiofrequency category. The clearance was granted under the Traditional 510(k) pathway, with a Substantially Equivalent determination by the FDA’s Cardiovascular (CV) Advisory Committee. The device is classified as Class II and falls under regulation number 870.2910.
Can the BL Healthcare Remote Care Management System (RCMS) be used in environments where MRI machines are present?
The regulatory data for the RCMS does not specify any MRI safety considerations, meaning there are no documented restrictions or guidelines regarding its use near MRI machines. However, since it is a radiofrequency-based device, caution should still be exercised to avoid interference with MRI operations, and users should follow manufacturer guidelines for safe coexistence.
How is the BL Healthcare Remote Care Management System (RCMS) installed, and who is responsible for this process?
The RCMS is installed by trained professionals, not patients or end-users. This ensures proper setup and functionality for remote monitoring. The manufacturer, BL Healthcare, Inc., provides the necessary support and documentation for installation, but the actual process is carried out by qualified personnel in the healthcare setting.
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: Telephone Based Bl Healthcare Remote Care Management System (Rcms), BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (K101078) — FDA 510(k ..., Telephone Based Bl Healthcare Remote Care Management System (Rcms) 510 ..., REMOTE CARE MANAGEMENT SYSTEMS (RCMS) by BL HEALTHCARE, INC. | FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052608 | Class II | Active |
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Manufacturer
- Manufacturer
- Bl Healthcare, Inc.
Sources (1)
- FDA 510(k) K052608 24 fields · synced Sep 19, 2026