Cleared Special

K113235 - PRESSURE DISPLAY BOX

K113235 is the FDA 510(k) clearance for PRESSURE DISPLAY BOX by Medtronic, Inc.. It is a Class 2 Cardiovascular device (product code DXS) cleared through the Special 510(k) pathway after a 30-day FDA review.

K113235 · Medtronic, Inc. · Cardiovascular device
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Dec 2011
Decision
30d
Days
Class 2
Risk

K113235 is an FDA 510(k) clearance for the PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS. Classified as Gauge, Pressure, Coronary, Cardiopulmonary Bypass (product code DXS), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 2, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4310 - 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 Medtronic, Inc. devices

Submission Details

510(k) Number K113235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2011
Decision Date December 02, 2011
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4310
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 - DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass

Devices cleared under the same product code (DXS) and FDA review panel - the closest regulatory comparables to K113235.
STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR
K900797 · Shiley, Inc. · May 1990
STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
K862836 · Shiley, Inc. · Sep 1986
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
K852232 · Dlp, Inc. · Aug 1985
GAMBRO PRESSURE MONITOR PRM 10
K822822 · Gambro, Inc. · Oct 1982
CORONARY PRESSURE PERFUSION PUMP
K771764 · 3M Health Care, Sarns · Sep 1977