Cleared Traditional

K953507 - TYPE 1 & 2 (HUMIDAIR I & II)

K953507 is an FDA 510(k) clearance for TYPE 1 & 2 (HUMIDAIR I & II), 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 43-day FDA review.

K953507 · Icor AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K953507

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
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 33
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K953507.
HEAT & MOISTURE EXCHANGER
K955008 · Intertech Resources, Inc. · Jan 1996
HEAT MOISTURE EXCHANGER
K953580 · Intertech Resources, Inc. · Sep 1995
EEE
K953540 · Edentec Corp. · Aug 1995
WARM N WET HME W/LUER ADAPTER
K953619 · Hospitak, Inc. · Aug 1995
WARM N WET HMEF W/LUER ADAPTER
K953620 · Hospitak, Inc. · Aug 1995
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
K952823 · Icor AB · Jul 1995