Cleared Traditional

K896380 - IC-2A MRI ADULT/PEDIATRIC VENTILATOR

K896380 is an FDA 510(k) clearance for IC-2A MRI ADULT/PEDIATRIC VENTILATOR, manufactured by Bio-Med Devices, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K896380 · Bio-Med Devices, Inc. · Anesthesiology device
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Feb 1990
Decision
98d
Days
Class 2
Risk

K896380 is an FDA 510(k) clearance for the IC-2A MRI ADULT/PEDIATRIC VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bio-Med Devices, Inc. (Madison, US). The FDA issued a Cleared decision on February 12, 1990 after a review of 98 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 Bio-Med Devices, Inc. devices

FDA 510(k) Submission Details - K896380

510(k) Number K896380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1989
Decision Date February 12, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
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 K896380.
V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR
K895541 · Bird Products Corp. · Mar 1990
TYPE 9290 INTERFACE RESPIRATOR
K896735 · S & W Medico Teknik · Feb 1990
TYPE 9291 INTERFACE RESPIRATOR
K896736 · S & W Medico Teknik · Feb 1990
8400ST VOLUME VENTILATOR
K894322 · Bird Products Corp. · Jan 1990
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989