Cleared Special

K022132 - SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E

K022132 is an FDA 510(k) clearance for SERVO VENTILATOR SYSTEM, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 80-day FDA review.

K022132 · Siemens Medical Solutions USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
80d
Days
Class 2
Risk

K022132 is an FDA 510(k) clearance for the SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on September 19, 2002 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022132

510(k) Number K022132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2002
Decision Date September 19, 2002
Days to Decision 80 days
Submission Type Special
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
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 504
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K022132.
INSPIRATION VENTILATOR SYSTEM
K021112 · eVent Medical, Ltd. · Nov 2002
BIRD AVEA VENTILATOR
K022674 · Bird Products Corp. · Nov 2002
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
K023350 · Respironics California, Inc. · Nov 2002
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
K021573 · Puritan-Bennett · Aug 2002
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
K012693 · Acutronic Medical Systems AG · Aug 2002
AVEA
K013642 · Bird Products Corp. · May 2002
K022132 · SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
Download PDF FDA Summary Siemens Medical Solut…