Cleared Traditional

K051470 - REMOTE CARE MANAGEMENT SYSTEMS (RCMS)

K051470 is an FDA 510(k) clearance for REMOTE CARE MANAGEMENT SYSTEMS (RCMS), manufactured by Bl Healthcare, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 5-day FDA review.

K051470 · Bl Healthcare, Inc. · Cardiovascular device
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Jun 2005
Decision
5d
Days
Class 2
Risk

K051470 is an FDA 510(k) clearance for the REMOTE CARE MANAGEMENT SYSTEMS (RCMS). Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Bl Healthcare, Inc. (Foxboro, US). The FDA issued a Cleared decision on June 8, 2005 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bl Healthcare, Inc. devices

FDA 510(k) Submission Details - K051470

510(k) Number K051470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2005
Decision Date June 08, 2005
Days to Decision 5 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 125d · This submission: 5d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 171
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K051470.
SENTRY OTC MONITOR
K061088 · Honeywell Hommed, LLC · Jun 2006
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
K052608 · Bl Healthcare, Inc. · Feb 2006
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
K052961 · Philips Medical Systems · Nov 2005
THE HERMES SYSTEM
K050929 · Palaistra Systems, Inc. · May 2005
VITALWARE VMS
K050128 · Televital, Inc. · May 2005
TELEREHAD 2004
K050778 · Scottcare · Apr 2005