Cleared Traditional

K881308 - BREATH-EASY (FDA 510(k) Clearance)

Class I Anesthesiology device.

K881308 · Icor AB · Anesthesiology device
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May 1988
Decision
50d
Days
Class 1
Risk

K881308 is an FDA 510(k) clearance for the BREATH-EASY. 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 May 17, 1988 after a review of 50 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 K881308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date May 17, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 139d · This submission: 50d
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.