Cleared Traditional

K891013 - MEDTRONIC INTRAVASCULAR BLOOD GAS MONIT...

K891013 is the FDA 510(k) clearance for MEDTRONIC INTRAVASCULAR BLOOD GAS MONIT... by Medtronic Vascular. It is a Class 2 Anesthesiology device (product code CCC) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K891013 · Medtronic Vascular · Anesthesiology device
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Aug 1989
Decision
155d
Days
Class 2
Risk

K891013 is an FDA 510(k) clearance for the MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING. Classified as Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling (product code CCC), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 2, 1989 after a review of 155 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1150 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K891013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date August 02, 1989
Days to Decision 155 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
15d slower than avg
Panel avg: 140d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1150
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 - CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

Devices cleared under the same product code (CCC) and FDA review panel - the closest regulatory comparables to K891013.
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K901548 · Shiley, Inc. · Jan 1991
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K870911 · American Bentley · May 1987
OXYGEN ANALYZER 110
K780185 · Siemens Corp. · Mar 1978
ANALYZER, SENTORR BLOOD GAS
K760088 · Ohio Medical Products · Aug 1976