Cleared Traditional

K802583 - INFANT VENTILATOR, (RESPIRATOR) PLAN B

K802583 is an FDA 510(k) clearance for INFANT VENTILATOR, manufactured by Healthdyne, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K802583 · Healthdyne, Inc. · Anesthesiology device
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Dec 1980
Decision
59d
Days
Class 2
Risk

K802583 is an FDA 510(k) clearance for the INFANT VENTILATOR, (RESPIRATOR) PLAN B. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Healthdyne, Inc. (Walker, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 59 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 Healthdyne, Inc. devices

FDA 510(k) Submission Details - K802583

510(k) Number K802583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1980
Decision Date December 18, 1980
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 140d · This submission: 59d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K802583.
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