Cleared Traditional

K023745 - SECHRIST AIR/OXYGEN MIXER

K023745 is an FDA 510(k) clearance for SECHRIST AIR/OXYGEN MIXER, manufactured by Sechrist Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DTX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K023745 · Sechrist Industries, Inc. · Cardiovascular device
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Jan 2003
Decision
71d
Days
Class 2
Risk

K023745 is an FDA 510(k) clearance for the SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G. Classified as Gas Control Unit, Cardiopulmonary Bypass (product code DTX), Class II - Special Controls.

Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4300 - 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 Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K023745

510(k) Number K023745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2002
Decision Date January 17, 2003
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTX Device Classification - Class 2, Special Controls

Product Code DTX Gas Control Unit, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4300
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 - DTX Gas Control Unit, Cardiopulmonary Bypass

All 7
Devices cleared under the same product code (DTX) and FDA review panel - the closest regulatory comparables to K023745.
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