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.

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
Combination Product No
PCCP Authorized No
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 33
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K915627.
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
K020587 · Pulsion Medical Systems AG · May 2002
PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
K991886 · Pulsion Medical Systems, Inc. · May 2000
CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
K936182 · Ohmeda Medical · Mar 1994
SAFEWEDGE(TM) RELIEF VALVE DEVICE
K912172 · Sunscope Intl., Inc. · Sep 1991
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
K902627 · Biometric Research Institute, Inc. · Feb 1991
INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER
K900710 · Intec Medical, Inc. · Oct 1990
K915627 · PACEVIEW
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