Cleared Traditional

K851288 - OXYGEN DELIVERY MEASURING DEVICE

K851288 is an FDA 510(k) clearance for OXYGEN DELIVERY MEASURING DEVICE, manufactured by Bar-Dix, Inc.. The device is a Class 1 Anesthesiology device with product code CAX cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K851288 · Bar-Dix, Inc. · Anesthesiology device
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Sep 1985
Decision
155d
Days
Class 1
Risk

K851288 is an FDA 510(k) clearance for the OXYGEN DELIVERY MEASURING DEVICE. Classified as Flowmeter, Tube, Thorpe, Back-pressure Compensated (product code CAX), Class I - General Controls.

Submitted by Bar-Dix, Inc. (Frazee, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 155 days - an extended review 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: 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.

FDA 510(k) Submission Details - K851288

510(k) Number K851288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date September 03, 1985
Days to Decision 155 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 140d · This submission: 155d
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 14
Devices cleared under the same product code (CAX) and FDA review panel - the closest regulatory comparables to K851288.
OHMEDA - LOW FLOW FLOWMETER
K910316 · Ohmeda Medical · Apr 1991
SERIES D FLOWMETER
K872718 · Puritan Bennett Corp. · Aug 1987
SELECT FLOWMETER
K854067 · Precision Medical, Inc. · Oct 1985
PRESSURE RELIEF ADAPTOR
K850559 · Precision Medical, Inc. · Apr 1985
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE
K850560 · Precision Medical, Inc. · Apr 1985
PRESET FLOWMETER
K812419 · Timeter Instrument Corp. · Sep 1981
K851288 · OXYGEN DELIVERY MEASURING DEVICE
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