Cleared Traditional

K904338 - ICOR HCH 4, ICOR HCH 7

K904338 is an FDA 510(k) clearance for ICOR HCH 4, manufactured by Icor AB. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 75-day FDA review.

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

FDA 510(k) Submission Details - K904338

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
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

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)

All 34
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K904338.
HEAT MOISTURE CONDENSER
K923910 · Concord/Portex · Jan 1993
BREATHE EASY
K914336 · Vital Signs, Inc. · Mar 1992
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · Intertech Resources, Inc. · Dec 1990
HUMIDI-FLEX TM
K885313 · Life Design Systems, Inc. · Oct 1989
THERMOVENT 600, 1200, T, 02
K874597 · Portex, Inc. · Jan 1988
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
K864095 · Gambro, Inc. · Feb 1987