Cleared Special

K011779 - AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM

K011779 is an FDA 510(k) clearance for AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM, manufactured by Avid Care Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 36-day FDA review.

K011779 · Avid Care Corp. · Cardiovascular device
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Jul 2001
Decision
36d
Days
Class 2
Risk

K011779 is an FDA 510(k) clearance for the AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Avid Care Corp. (Washington, US). The FDA issued a Cleared decision on July 13, 2001 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Avid Care Corp. devices

FDA 510(k) Submission Details - K011779

510(k) Number K011779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2001
Decision Date July 13, 2001
Days to Decision 36 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 125d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

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