Cleared Traditional

K954194 - DISPOSABLE HME/FILTER

K954194 is an FDA 510(k) clearance for DISPOSABLE HME/FILTER, manufactured by Engstrom Medical. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K954194 · Engstrom Medical · Anesthesiology device
Download Printable Device Report (PDF)
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Oct 1995
Decision
44d
Days
Class 1
Risk

K954194 is an FDA 510(k) clearance for the DISPOSABLE HME/FILTER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Engstrom Medical (Sturgis, US). The FDA issued a Cleared decision on October 20, 1995 after a review of 44 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 Engstrom Medical devices

FDA 510(k) Submission Details - K954194

510(k) Number K954194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date October 20, 1995
Days to Decision 44 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
96d faster than avg
Panel avg: 140d · This submission: 44d
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 K954194.
HEAT & MOISTURE EXCHANGER
K955008 · Intertech Resources, Inc. · Jan 1996
HEAT MOISTURE EXCHANGER
K953580 · Intertech Resources, Inc. · Sep 1995
TYPE 1 & 2 (HUMIDAIR I & II)
K953507 · Icor AB · 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