Cleared Traditional

K934190 - HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION

K934190 is an FDA 510(k) clearance for HME W/O FILTER HYGROFLEX, manufactured by Bird Life Design. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K934190 · Bird Life Design · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
90d
Days
Class 1
Risk

K934190 is an FDA 510(k) clearance for the HME W/O FILTER HYGROFLEX, HYGROFLEX-T, MODIFICATION. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Bird Life Design (Dallas, US). The FDA issued a Cleared decision on November 24, 1993 after a review of 90 days - within the typical 510(k) review window.

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 Bird Life Design devices

FDA 510(k) Submission Details - K934190

510(k) Number K934190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1993
Decision Date November 24, 1993
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 K934190.
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