Cleared Traditional

K813253 - IC-5 VENTILATOR

K813253 is an FDA 510(k) clearance for IC-5 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 20-day FDA review.

K813253 · Bio-Med Devices, Inc. · Anesthesiology device
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Dec 1981
Decision
20d
Days
Class 2
Risk

K813253 is an FDA 510(k) clearance for the IC-5 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bio-Med Devices, Inc. (Walker, US). The FDA issued a Cleared decision on December 9, 1981 after a review of 20 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Med Devices, Inc. devices

FDA 510(k) Submission Details - K813253

510(k) Number K813253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1981
Decision Date December 09, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 140d · This submission: 20d
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 K813253.
VENTILATOR MODELS
K820220 · Pneupac , Ltd. · Feb 1982
JET VENTILATOR
K813254 · Healthdyne, Inc. · Feb 1982
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982
ENGSTROM ERICA
K812642 · Lkb Instruments, Inc. · Nov 1981
HEWLETT-PACKARD VENTILATOR
K810893 · Hewlett-Packard Co. · Jun 1981
SECHRIST INFANT VENTRILATOR MODEL IV-100
K811141 · Sechrist Industries, Inc. · Jun 1981