Cleared Traditional

K923444 - SERVO GRAPHICS

K923444 is an FDA 510(k) clearance for SERVO GRAPHICS, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K923444 · Siemens Medical Solutions USA, Inc. · Anesthesiology device
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Mar 1993
Decision
235d
Days
Class 2
Risk

K923444 is an FDA 510(k) clearance for the SERVO GRAPHICS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 5, 1993 after a review of 235 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 Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K923444

510(k) Number K923444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date March 05, 1993
Days to Decision 235 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 140d · This submission: 235d
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 371
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K923444.
BIRD AVIAN PORT MILITARY VENT NSN 6530-01-374-8903
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POWER PACK 350/BATTERY PACK 351
K923992 · Siemens Medical Solutions USA, Inc. · Apr 1993
BIRD 8400ST ADULT VOLUME VENTILATOR
K921387 · Bird Products Corp. · Mar 1993
BIRD GRAPHICS MONITOR
K920113 · Bird Products Corp. · Feb 1993
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR INTERFACE 9291/4
K922314 · S & W Medico Teknik · Dec 1992