Cleared Traditional

K923910 - HEAT MOISTURE CONDENSER

K923910 is the FDA 510(k) clearance for HEAT MOISTURE CONDENSER by Concord/Portex. It is a Class 1 Anesthesiology device (product code BYD) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K923910 · Concord/Portex · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
175d
Days
Class 1
Risk

K923910 is an FDA 510(k) clearance for the HEAT MOISTURE CONDENSER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 175 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 Concord/Portex devices

Submission Details

510(k) Number K923910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date January 26, 1993
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
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.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K923910.
FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT
K950447 · Vital Signs, Inc. · Feb 1995
5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID
K923865 · Vital Signs, Inc. · Feb 1993
BREATHE EASY
K914336 · Vital Signs, Inc. · Mar 1992
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
K864095 · Gambro, Inc. · Feb 1987
INLINE FOAM NOSE
K840398 · Mallinckrodt Critical Care · Mar 1984
FOAM NOSE
K840399 · Mallinckrodt Critical Care · Mar 1984