Cleared Traditional

K893786 - SERVO ANESTHESIA CIRCLE 985

K893786 is an FDA 510(k) clearance for SERVO ANESTHESIA CIRCLE 985, manufactured by Siemens Life Support Systems. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K893786 · Siemens Life Support Systems · Anesthesiology device
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Sep 1989
Decision
123d
Days
Class 2
Risk

K893786 is an FDA 510(k) clearance for the SERVO ANESTHESIA CIRCLE 985. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Life Support Systems (Schaumburg, US). The FDA issued a Cleared decision on September 22, 1989 after a review of 123 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K893786

510(k) Number K893786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date September 22, 1989
Days to Decision 123 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 140d · This submission: 123d
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 443
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K893786.
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989
BIRD (VDR) SINUSOIDAL PERCUSSIONATORS
K895486 · Percussionaire Corp. · Oct 1989
LEONARDO INFORMATION SYSTEM
K894426 · Hamilton Medical, Inc. · Sep 1989
AMADEUS VENTILATOR
K894316 · Hamilton Medical, Inc. · Sep 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989
NEWPORT VENTILATOR MODEL E150
K883809 · Newport Medical Instruments, Inc. · Jun 1989
K893786 · SERVO ANESTHESIA CIRCLE 985
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