Cleared Traditional

K811414 - BAIM CORONARY SINUS FLOW ANALYZER

K811414 is an FDA 510(k) clearance for BAIM CORONARY SINUS FLOW ANALYZER, manufactured by Electro-Catheter Corp.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K811414 · Electro-Catheter Corp. · Cardiovascular device
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Jun 1981
Decision
24d
Days
Class 2
Risk

K811414 is an FDA 510(k) clearance for the BAIM CORONARY SINUS FLOW ANALYZER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 24 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 Electro-Catheter Corp. devices

FDA 510(k) Submission Details - K811414

510(k) Number K811414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1981
Decision Date June 12, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
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 85
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K811414.
ANERIOD GAUZE
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CARDIAC REVIEW STATION
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AM 420 MICROPROCESSOR
K810163 · Honeywell, Inc. · Mar 1981
TREND GRAPH FUNCTION BLOCK
K810170 · Honeywell, Inc. · Feb 1981
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K810177 · Honeywell, Inc. · Feb 1981