Cleared Traditional

K943412 - VENTURI VENTILATOR

K943412 is an FDA 510(k) clearance for VENTURI VENTILATOR, manufactured by Cardiopulmonary Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 459-day FDA review.

K943412 · Cardiopulmonary Corp. · Anesthesiology device
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Oct 1995
Decision
459d
Days
Class 2
Risk

K943412 is an FDA 510(k) clearance for the VENTURI VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Cardiopulmonary Corp. (Milford, US). The FDA issued a Cleared decision on October 16, 1995 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Cardiopulmonary Corp. devices

FDA 510(k) Submission Details - K943412

510(k) Number K943412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 14, 1994
Decision Date October 16, 1995
Days to Decision 459 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
319d slower than avg
Panel avg: 140d · This submission: 459d
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 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K943412.
TBIRD VS VENTILATOR AND TBIRD AVS VENTILATOR
K950484 · Bird Products Corp. · May 1996
NARKOMED AV2+ ANESTHESIA VENTILATOR
K953228 · Draeger Medical, Inc. · Mar 1996
ADULT VENTILATOR
K943106 · Infrasonics Corp. · Dec 1995
NEWPORT ELECTRONIC MANOMETER
K941308 · Newport Medical Instruments, Inc. · Aug 1995
OXYLOG 2000
K943531 · Drager, Inc. · Aug 1995
NEWPORT ELECTRONIC MANOMETER
K941309 · Newport Medical Instruments, Inc. · Mar 1995