Cleared Traditional

K915627 - PACEVIEW

K915627 is an FDA 510(k) clearance for PACEVIEW, manufactured by Micromedical Industries, Ltd.. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K915627 · Micromedical Industries, Ltd. · Cardiovascular device
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Mar 1992
Decision
109d
Days
Class 2
Risk

K915627 is an FDA 510(k) clearance for the PACEVIEW. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Micromedical Industries, Ltd. (Northbrook, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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 Micromedical Industries, Ltd. devices

FDA 510(k) Submission Details - K915627

510(k) Number K915627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date March 27, 1992
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRB Device Classification - Class 2, Special Controls

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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 - KRB Probe, Thermodilution

All 25
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K915627.
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
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CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
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INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · Intec Medical, Inc. · Oct 1990
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · NuMED, Inc. · Sep 1988