Cleared Traditional

K901926 - SORBA MODEL CIC-1000 W/NEW ELECTRODES

K901926 is an FDA 510(k) clearance for SORBA MODEL CIC-1000 W/NEW ELECTRODES, manufactured by Sorba Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K901926 · Sorba Medical Systems, Inc. · Cardiovascular device
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Jun 1990
Decision
43d
Days
Class 2
Risk

K901926 is an FDA 510(k) clearance for the SORBA MODEL CIC-1000 W/NEW ELECTRODES. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Sorba Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Sorba Medical Systems, Inc. devices

FDA 510(k) Submission Details - K901926

510(k) Number K901926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date June 12, 1990
Days to Decision 43 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 106
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