Cleared Traditional

K871354 - SERVO VENTILATOR 900 C/D

K871354 is an FDA 510(k) clearance for SERVO VENTILATOR 900 C/D, 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 106-day FDA review.

K871354 · Siemens Elema AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
106d
Days
Class 2
Risk

K871354 is an FDA 510(k) clearance for the SERVO VENTILATOR 900 C/D. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Siemens Elema AB (Schaumburg, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 106 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.

View all Siemens Elema AB devices

FDA 510(k) Submission Details - K871354

510(k) Number K871354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1987
Decision Date July 21, 1987
Days to Decision 106 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
34d faster than avg
Panel avg: 140d · This submission: 106d
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 K871354.
PRESSURE LIMIT CONTROL
K874415 · Draeger Medical, Inc. · Jan 1988
ASCENDING VENTILATOR BELLOWS
K874371 · Draeger Medical, Inc. · Dec 1987
PEDIATRIC BELLOWS
K873549 · Draeger Medical, Inc. · Oct 1987
BEAR JET VENTILATOR FOR USE DURING (ESWL)
K871985 · Bear Medical Systems, Inc. · Jun 1987
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · Ohmeda Medical · May 1987
COMPANION 2800 PORTABLE VOLUME VENTILATOR
K870275 · Puritan Bennett Corp. · Mar 1987