Cleared Traditional

K812961 - SHEFFIELD INFANT VENTILATOR MARK 4

K812961 is an FDA 510(k) clearance for SHEFFIELD INFANT VENTILATOR MARK 4, manufactured by Cairco , Ltd.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K812961 · Cairco , Ltd. · Anesthesiology device
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Mar 1982
Decision
156d
Days
Class 2
Risk

K812961 is an FDA 510(k) clearance for the SHEFFIELD INFANT VENTILATOR MARK 4. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Cairco , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 26, 1982 after a review of 156 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 Cairco , Ltd. devices

FDA 510(k) Submission Details - K812961

510(k) Number K812961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1981
Decision Date March 26, 1982
Days to Decision 156 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 140d · This submission: 156d
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 400
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K812961.
SECHRIST MODEL 990 JET VENTILATOR
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K821376 · Ohio Medical Products · Jun 1982
NEWPORT VENTILATOR MODEL E100
K820746 · Newport Medical Instruments, Inc. · Apr 1982
ANESTHESIA VENTILATOR
K820393 · Puritan Bennett Corp. · Mar 1982
VENTILATOR MODELS
K820220 · Pneupac , Ltd. · Feb 1982
JET VENTILATOR
K813254 · Healthdyne, Inc. · Feb 1982