Cleared Special

K111096 - VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY

K111096 is an FDA 510(k) clearance for VASOMEDICAL-BIOX COMBINED 12 CHANNEL AM..., manufactured by Vasomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Special 510(k) pathway after a 65-day FDA review.

K111096 · Vasomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
65d
Days
Class 2
Risk

K111096 is an FDA 510(k) clearance for the VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORD.... Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Vasomedical, Inc. (Westbury, US). The FDA issued a Cleared decision on June 24, 2011 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 - K111096

510(k) Number K111096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2011
Decision Date June 24, 2011
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 192
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K111096.
GLOBALCARDIO
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K101022 · Karmelsonix · Jul 2010
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
K092785 · Vasomedical, Inc. · Apr 2010
COR12+
K091505 · Viasys Healthcare GmbH · Jun 2009
K111096 · VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER MODEL 2302, VASOMEDICAL-BIOX AMBULATORY
Download PDF FDA Summary Vasomedical, Inc.