Cleared Traditional

K920121 - SECHRIST IV-100B SAVI SYSTEM

K920121 is an FDA 510(k) clearance for SECHRIST IV-100B SAVI SYSTEM, manufactured by Sechrist. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K920121 · Sechrist · Anesthesiology device
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Feb 1993
Decision
385d
Days
Class 2
Risk

K920121 is an FDA 510(k) clearance for the SECHRIST IV-100B SAVI SYSTEM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Sechrist (Anaheim, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 devices

FDA 510(k) Submission Details - K920121

510(k) Number K920121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1992
Decision Date February 01, 1993
Days to Decision 385 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
245d slower than avg
Panel avg: 140d · This submission: 385d
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 413
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K920121.
BIRD 8400ST ADULT VOLUME VENTILATOR
K921387 · Bird Products Corp. · Mar 1993
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · 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
VENTILATOR ADULT STAR MODIFICATION
K922654 · Infrasonics Corp. · Dec 1992