Cleared Special

K080670 - MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

K080670 is an FDA 510(k) clearance for MODIFICATION TO SPHYGMOCOR CARDIOVASCUL..., manufactured by Atcor Medical. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Special 510(k) pathway after a 44-day FDA review.

K080670 · Atcor Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
44d
Days
Class 2
Risk

K080670 is an FDA 510(k) clearance for the MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Atcor Medical (West Ryde Nsw, AU). The FDA issued a Cleared decision on April 23, 2008 after a review of 44 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K080670

510(k) Number K080670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date April 23, 2008
Days to Decision 44 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

DSK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DSK Computer, Blood-pressure

All 56
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K080670.
Endophys Blood Pressure Monitor
K160945 · Endophys Holdings, LLC · Sep 2016
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · Volcano Corporation · Dec 2015
ENDOPHYS BLOOD PRESSURE MONITOR
K141615 · Endophys, Inc. · Jan 2015
SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
K070795 · Atcor Medical Pty, Ltd. · Aug 2007
MONITORING SYSTEM, MODEL ARGUS PB-2200
K033738 · Schiller AG · Aug 2004
ABP FOR WINDOWS
K021517 · Rozinn Electronics, Inc. · Jul 2002