Cleared Traditional

K904338 - ICOR HCH 4, ICOR HCH 7 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K904338 · Icor AB · Anesthesiology device
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Dec 1990
Decision
75d
Days
Class 1
Risk

K904338 is an FDA 510(k) clearance for the ICOR HCH 4, ICOR HCH 7. 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 December 4, 1990 after a review of 75 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 K904338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1990
Decision Date December 04, 1990
Days to Decision 75 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 139d · This submission: 75d
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.