Cleared Traditional

K953507 - TYPE 1 & 2 (HUMIDAIR I & II) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K953507 · Icor AB · Anesthesiology device
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Sep 1995
Decision
43d
Days
Class 1
Risk

K953507 is an FDA 510(k) clearance for the TYPE 1 & 2 (HUMIDAIR I & II). 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 September 7, 1995 after a review of 43 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 K953507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1995
Decision Date September 07, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 139d · This submission: 43d
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.