Cleared Traditional

K010164 - ICG MODULE

K010164 is an FDA 510(k) clearance for ICG MODULE, manufactured by General Electric Medical Systems Information Techn. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K010164 · General Electric Medical Systems Information Techn · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
81d
Days
Class 2
Risk

K010164 is an FDA 510(k) clearance for the ICG MODULE. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by General Electric Medical Systems Information Techn (Milwaukee, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Electric Medical Systems Information Techn devices

FDA 510(k) Submission Details - K010164

510(k) Number K010164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2001
Decision Date April 09, 2001
Days to Decision 81 days
Submission Type Traditional
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
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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 - DSB Plethysmograph, Impedance

All 52
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K010164.
BIOZDX HEMODYNAMIC MONITOR
K041294 · Cardiodynamics International Corp. · Dec 2004
ZOE FLUID STATUS MONITOR
K042113 · Noninvasive Medical Technologies, LLC · Sep 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · Analogic Corp. · Aug 2004
IQ SYSTEM
K981720 · Renaissance Technology, Inc. · Feb 1999
BIOZ.COM SYSTEM
K974725 · Cardiodynamics International Corp. · Mar 1998
PERCUPUMP II WITH EDA
K974621 · E-Z-Em, Inc. · Jan 1998