Cleared Traditional

K812961 - SHEFFIELD INFANT VENTILATOR MARK 4

K812961 is the FDA 510(k) clearance for SHEFFIELD INFANT VENTILATOR MARK 4 by Cairco , Ltd.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 K812961.
7200 MICROPROCESSOR VENTILATOR
K841757 · Puritan Bennett Corp. · May 1984
MICROPROCESSOR VENTILATOR 7200
K833786 · Puritan Bennett Corp. · Dec 1983
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