Cleared Traditional

K962128 - TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)

K962128 is an FDA 510(k) clearance for TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE..., manufactured by Hemo Sapiens, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K962128 · Hemo Sapiens, Inc. · Cardiovascular device
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Nov 1996
Decision
171d
Days
Class 2
Risk

K962128 is an FDA 510(k) clearance for the TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT). Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Hemo Sapiens, Inc. (Irvine, US). The FDA issued a Cleared decision on November 21, 1996 after a review of 171 days - an extended review 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: 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 Hemo Sapiens, Inc. devices

FDA 510(k) Submission Details - K962128

510(k) Number K962128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1996
Decision Date November 21, 1996
Days to Decision 171 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
46d slower than avg
Panel avg: 125d · This submission: 171d
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

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