Cleared Traditional

K833982 - MODEL IV 100B-DA INFANT VENTILATOR

K833982 is an FDA 510(k) clearance for MODEL IV 100B-DA INFANT VENTILATOR, 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 109-day FDA review.

K833982 · Sechrist Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
109d
Days
Class 2
Risk

K833982 is an FDA 510(k) clearance for the MODEL IV 100B-DA INFANT VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Sechrist Industries, Inc. (Walker, US). The FDA issued a Cleared decision on March 5, 1984 after a review of 109 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 Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K833982

510(k) Number K833982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1983
Decision Date March 05, 1984
Days to Decision 109 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 140d · This submission: 109d
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 K833982.
AB MANUAL VENTILATION ACCESS. 900C
K841393 · Siemens Elema AB · May 1984
7200 MICROPROCESSOR VENTILATOR
K841757 · Puritan Bennett Corp. · May 1984
CONTINUOUS VENTILATOR
K840119 · Bear Medical Systems, Inc. · Apr 1984
IMPULSE VENTILATOR
K840345 · Healthdyne, Inc. · Feb 1984
MICROPROCESSOR VENTILATOR 7200
K833786 · Puritan Bennett Corp. · Dec 1983
PZ-800 VOLUME VENTILATOR
K822835 · Narco Scientific · Sep 1983