Cleared Traditional

SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (K070795) - FDA 510(k) Clearance

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

K070795 · Atcor Medical Pty, Ltd. · Cardiovascular device
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Aug 2007
Decision
162d
Days
Class 2
Risk

K070795 is an FDA 510(k) clearance for the SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Atcor Medical Pty, Ltd. (Washington, D.C., US). The FDA issued a Cleared decision on August 31, 2007 after a review of 162 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Atcor Medical Pty, Ltd. devices

Submission Details

510(k) Number K070795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2007
Decision Date August 31, 2007
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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.