Cleared Traditional

K896269 - SECHRIST VOLUME VENTILATOR MODEL 2200B

K896269 is an FDA 510(k) clearance for SECHRIST VOLUME VENTILATOR MODEL 2200B, manufactured by Sechrist Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K896269 · Sechrist Industries, Inc. · Anesthesiology device
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May 1990
Decision
199d
Days
Class 2
Risk

K896269 is an FDA 510(k) clearance for the SECHRIST VOLUME VENTILATOR MODEL 2200B. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on May 18, 1990 after a review of 199 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 Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K896269

510(k) Number K896269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1989
Decision Date May 18, 1990
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
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 250
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K896269.
MODEL LP6 VENTILATOR, MODIFICATION
K905244 · Aequitron Medical, Inc. · Nov 1990
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990
BEAR CEM CONTROLLER
K900637 · Bear Medical Systems, Inc. · Aug 1990
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
K897113 · Puritan Bennett Corp. · Mar 1990
MODIFIED 225/SIMV VOLUME VENTILATOR
K884389 · Monaghan Medical Corp. · Mar 1990
V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR
K895541 · Bird Products Corp. · Mar 1990