Cleared Traditional

K946044 - DISPOSABLE GAS SAMPLING LINES

K946044 is an FDA 510(k) clearance for DISPOSABLE GAS SAMPLING LINES, manufactured by Catheter Research, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K946044 · Catheter Research, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
15d
Days
Class 2
Risk

K946044 is an FDA 510(k) clearance for the DISPOSABLE GAS SAMPLING LINES. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Catheter Research, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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: 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 Catheter Research, Inc. devices

FDA 510(k) Submission Details - K946044

510(k) Number K946044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1994
Decision Date December 27, 1994
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 187
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K946044.
SMART ANESTHESIA MULTI-GAS (SAM) MODULE
K943977 · Marquette Electronics, Inc. · Mar 1995
SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM
K943389 · Hewlett-Packard Co. · Mar 1995
HANDYPACK 911SC
K944541 · Pace Tech, Inc. · Feb 1995
9100 MUTIGAS MONITOR
K941971 · Bci Intl., Inc. · Nov 1994
COMET CAPNOGRAPH MODULE
K941165 · Spacelabs, Inc. · Oct 1994
PEDI-CAP
K944400 · Nellcor, Inc. · Sep 1994