Cleared Traditional

K900150 - HCH 9165

K900150 is the FDA 510(k) clearance for HCH 9165 by Icor AB. It is a Class 1 Anesthesiology device (product code BYD) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K900150 · Icor AB · Anesthesiology device
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Jan 1990
Decision
14d
Days
Class 1
Risk

K900150 is an FDA 510(k) clearance for the HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on January 25, 1990 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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 Icor AB devices

Submission Details

510(k) Number K900150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1990
Decision Date January 25, 1990
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

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