Cleared Traditional

K050381 - CS MEDICAL TTCF GAS DELIVERY SYSTEM

K050381 is an FDA 510(k) clearance for CS MEDICAL TTCF GAS DELIVERY SYSTEM, manufactured by Cs Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K050381 · Cs Medical, Inc. · Anesthesiology device
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Jul 2005
Decision
148d
Days
Class 2
Risk

K050381 is an FDA 510(k) clearance for the CS MEDICAL TTCF GAS DELIVERY SYSTEM. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Cs Medical, Inc. (Boulder, US). The FDA issued a Cleared decision on July 13, 2005 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cs Medical, Inc. devices

FDA 510(k) Submission Details - K050381

510(k) Number K050381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2005
Decision Date July 13, 2005
Days to Decision 148 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 140d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZR Device Classification - Class 2, Special Controls

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 27
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K050381.
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K973646 · Bird Products Corp. · May 1998
OXY/STAR LOW FLOW BLENDER
K952878 · Infrasonics Corp. · Sep 1995