Cleared Traditional

K970839 - SERVO VENTILATOR 300A

K970839 is an FDA 510(k) clearance for SERVO VENTILATOR 300A, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 221-day FDA review.

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

FDA 510(k) Submission Details - K970839

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 140d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 239
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K970839.
DIVAN ANESTHESIA VENTILATOR
K980208 · Draeger Medical, Inc. · Aug 1998
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
K970460 · Puritan Bennett Corp. · Apr 1998
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
K964540 · Puritan Bennett Corp. · Nov 1997
NELLCOR PURITAN BENNETT GEMINI
K972248 · Nellcor Puritan Bennett, Inc. · Sep 1997
INFRASONICS ADULT VENTILATOR TRENDING OPTION
K964543 · Nellcor Puritan Bennett, Inc. · Feb 1997
SERVO VENTILATOR 300 COMPUTER INTERFACE
K960010 · Siemens Elema AB · Oct 1996