Cleared Traditional

K801890 - IC-2 VENTILATOR

K801890 is an FDA 510(k) clearance for IC-2 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 102-day FDA review.

K801890 · Bio-Med Devices, Inc. · Anesthesiology device
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Nov 1980
Decision
102d
Days
Class 2
Risk

K801890 is an FDA 510(k) clearance for the IC-2 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bio-Med Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 18, 1980 after a review of 102 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 - K801890

510(k) Number K801890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1980
Decision Date November 18, 1980
Days to Decision 102 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 140d · This submission: 102d
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 423
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K801890.
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
K811102 · Siemens Elema AB · May 1981
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · Draeger Medical, Inc. · Dec 1980
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · Healthdyne, Inc. · Dec 1980
BABYBIRD 2 VENTILATOR
K802087 · Bird Products Corp. · Oct 1980
CAM-10 EXSUFFLATION BELT #11-001
K800999 · Lifecare Services, Inc. · May 1980
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
K800650 · Hospal Medical Corp. · Apr 1980