Cleared Traditional

K812016 - VS600 JET VENTILATOR

K812016 is the FDA 510(k) clearance for VS600 JET VENTILATOR by Instrument Development Corp.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K812016 · Instrument Development Corp. · Anesthesiology device
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Dec 1981
Decision
166d
Days
Class 2
Risk

K812016 is an FDA 510(k) clearance for the VS600 JET VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Instrument Development Corp. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1981 after a review of 166 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 Instrument Development Corp. devices

Submission Details

510(k) Number K812016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1981
Decision Date December 30, 1981
Days to Decision 166 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 140d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K812016.
VOLUME VENTILATOR
K823858 · Puritan Bennett Corp. · Dec 1982
ANESTHESIA VENTILATOR
K820393 · Puritan Bennett Corp. · Mar 1982
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982
HEWLETT-PACKARD VENTILATOR
K810893 · Hewlett-Packard Co. · Jun 1981
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · Draeger Medical, Inc. · Dec 1980