Cleared Traditional

K863675 - CALIBRATION GAS FOR SERVO GAS MONITOR 120 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K863675 · Siemens Elema AB · Anesthesiology device
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Nov 1986
Decision
45d
Days
Class 1
Risk

K863675 is an FDA 510(k) clearance for the CALIBRATION GAS FOR SERVO GAS MONITOR 120. Classified as Gas, Calibration (specified Concentration) (product code BXK), Class I - General Controls.

Submitted by Siemens Elema AB (Schaumburg, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6400 - 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 Elema AB devices

Submission Details

510(k) Number K863675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date November 03, 1986
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 139d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXK Gas, Calibration (specified Concentration)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6400
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.