Cleared Traditional

K811141 - SECHRIST INFANT VENTRILATOR MODEL IV-100

K811141 is an FDA 510(k) clearance for SECHRIST INFANT VENTRILATOR MODEL IV-100, 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 46-day FDA review.

K811141 · Sechrist Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
46d
Days
Class 2
Risk

K811141 is an FDA 510(k) clearance for the SECHRIST INFANT VENTRILATOR MODEL IV-100. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Sechrist Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 46 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 Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K811141

510(k) Number K811141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1981
Decision Date June 12, 1981
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
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 K811141.
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
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
K811102 · Siemens Elema AB · May 1981
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · Draeger Medical, Inc. · Dec 1980
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · Healthdyne, Inc. · Dec 1980