Cleared Special

K110779 - SPACELABS SMART DISCLOSURE SYSTEM

K110779 is an FDA 510(k) clearance for SPACELABS SMART DISCLOSURE SYSTEM, manufactured by Spacelabs Healthcare. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 29-day FDA review.

K110779 · Spacelabs Healthcare · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
29d
Days
Class 2
Risk

K110779 is an FDA 510(k) clearance for the SPACELABS SMART DISCLOSURE SYSTEM. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Spacelabs Healthcare (Nederland, US). The FDA issued a Cleared decision on April 19, 2011 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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.

FDA 510(k) Submission Details - K110779

510(k) Number K110779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date April 19, 2011
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 411
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K110779.
MUSE CARDIOLOGY INFORMATION SYSTEM
K110132 · Ge Medical Systems Information Technologies, Inc. · May 2011
4D LV-ANALYSIS 3.0
K110746 · Tomtec Imaging Systems GmbH · May 2011
ENSITE VELOCITY SYSTEM
K110549 · St Jude Medical · May 2011
CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
K103678 · Ge Medical Systems Information Technologies GmbH · Feb 2011
4D MV-ASSESSMENT 2.0
K103782 · Tomtec Imaging Systems GmbH · Jan 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
K103746 · Biosense Webster, Inc. · Jan 2011