Cleared Traditional

K791069 - LINDE OXYGEN THERAPY FLOWMETERS

K791069 is an FDA 510(k) clearance for LINDE OXYGEN THERAPY FLOWMETERS, manufactured by Union Carbide Corp.. The device is a Class 1 Anesthesiology device with product code CAX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K791069 · Union Carbide Corp. · Anesthesiology device
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Jun 1979
Decision
15d
Days
Class 1
Risk

K791069 is an FDA 510(k) clearance for the LINDE OXYGEN THERAPY FLOWMETERS, L33-L34. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1979 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2340 - 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K791069

510(k) Number K791069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date June 27, 1979
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

CAX Device Classification - Class 1, General Controls

Product Code CAX Flowmeter, Tube, Thorpe, Back-pressure Compensated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2340
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CAX Flowmeter, Tube, Thorpe, Back-pressure Compensated

All 12
Devices cleared under the same product code (CAX) and FDA review panel - the closest regulatory comparables to K791069.
M015 OXYGEN & MA15 AIR
K791900 · Timeter Instrument Corp. · Oct 1979
FLOWMETER, BACK PRESSURE COMPENSATED,
K791220 · Timeter Instrument Corp. · Aug 1979
FLOW LIMITER
K791017 · Timeter Instrument Corp. · Jul 1979
FLOWMETER, P.C., REDESIGNED VERSION
K760102 · Ohio Medical Products · Jul 1976