Cleared Traditional

K780185 - OXYGEN ANALYZER 110

K780185 is the FDA 510(k) clearance for OXYGEN ANALYZER 110 by Siemens Corp.. It is a Class 2 Anesthesiology device (product code CCC) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K780185 · Siemens Corp. · Anesthesiology device
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Mar 1978
Decision
39d
Days
Class 2
Risk

K780185 is an FDA 510(k) clearance for the OXYGEN ANALYZER 110. Classified as Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling (product code CCC), Class II - Special Controls.

Submitted by Siemens Corp. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1978 after a review of 39 days - a notably fast clearance 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: 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 Siemens Corp. devices

Submission Details

510(k) Number K780185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1978
Decision Date March 17, 1978
Days to Decision 39 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
101d faster than avg
Panel avg: 140d · This submission: 39d
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 K780185.
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K901548 · Shiley, Inc. · Jan 1991
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013 · Medtronic Vascular · Aug 1989
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K870911 · American Bentley · May 1987
SENSOMAT
K771722 · Biochem International, Inc. · Sep 1977
ANALYZER, SENTORR BLOOD GAS
K760088 · Ohio Medical Products · Aug 1976