Cleared Traditional

K811102 - SIEMENS-ELEMA AB SERVO VENTILATOR 900 C

K811102 is an FDA 510(k) clearance for SIEMENS-ELEMA AB SERVO VENTILATOR 900 C, 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 14-day FDA review.

K811102 · Siemens Elema AB · Anesthesiology device
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May 1981
Decision
14d
Days
Class 2
Risk

K811102 is an FDA 510(k) clearance for the SIEMENS-ELEMA AB SERVO VENTILATOR 900 C. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Elema AB (Walker, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 14 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Elema AB devices

FDA 510(k) Submission Details - K811102

510(k) Number K811102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date May 05, 1981
Days to Decision 14 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
126d faster than avg
Panel avg: 140d · This submission: 14d
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 K811102.
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982
ENGSTROM ERICA
K812642 · Lkb Instruments, Inc. · Nov 1981
HEWLETT-PACKARD VENTILATOR
K810893 · Hewlett-Packard Co. · Jun 1981
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · Draeger Medical, Inc. · Dec 1980
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · Healthdyne, Inc. · Dec 1980
BABYBIRD 2 VENTILATOR
K802087 · Bird Products Corp. · Oct 1980