Cleared Traditional

K925622 - FHB, FHB-T, FHBFLEX, FHBFLEX-T

K925622 is an FDA 510(k) clearance for FHB, 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 201-day FDA review.

K925622 · Icor AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
201d
Days
Class 1
Risk

K925622 is an FDA 510(k) clearance for the FHB, FHB-T, FHBFLEX, FHBFLEX-T. 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 26, 1993 after a review of 201 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Icor AB devices

FDA 510(k) Submission Details - K925622

510(k) Number K925622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date May 26, 1993
Days to Decision 201 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
61d slower than avg
Panel avg: 140d · This submission: 201d
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 K925622.
TRACHEOLIFE
K941535 · Mallinckrodt Medical · Apr 1994
HEPA FILTERED HEAT AND MOISTURE EXCHANGER
K935036 · Intertech Resources, Inc. · Jan 1994
KING SYSTEMS HME
K934441 · King Systems Corp. · Dec 1993
VAPORTEMP HEAT AND MOISTURE EXCHANGER
K922946 · Mallinckrodt Medical · Mar 1993
5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID
K923865 · Vital Signs, Inc. · Feb 1993
HEAT MOISTURE CONDENSER
K923910 · Concord/Portex · Jan 1993