Cleared Traditional

K970839 - SERVO VENTILATOR 300A (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970839 · Siemens Elema AB · Anesthesiology device
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Oct 1997
Decision
221d
Days
Class 2
Risk

K970839 is an FDA 510(k) clearance for the SERVO VENTILATOR 300A. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Elema AB (S-17195 Solna, SE). The FDA issued a Cleared decision on October 14, 1997 after a review of 221 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Siemens Elema AB devices

Submission Details

510(k) Number K970839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 07, 1997
Decision Date October 14, 1997
Days to Decision 221 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 139d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 503
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