Cleared Traditional

VITALCAREGIVING SYSTEM (K051544) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K051544 · Advanced Monitoring Caregiving, Inc. · Cardiovascular device
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Oct 2005
Decision
119d
Days
Class 2
Risk

K051544 is an FDA 510(k) clearance for the VITALCAREGIVING SYSTEM. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Advanced Monitoring Caregiving, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Monitoring Caregiving, Inc. devices

Submission Details

510(k) Number K051544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2005
Decision Date October 07, 2005
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 53
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K051544.
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K913533 · Hewlett-Packard Co. · Nov 1991
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K912084 · Medtronic Vascular · Jul 1991