Cleared Traditional

K946209 - DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME

K946209 is an FDA 510(k) clearance for DISPODABLE HEAT & MOISTURE EXCHANGER AN..., manufactured by Med-Plastics Intl., Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K946209 · Med-Plastics Intl., Inc. · Anesthesiology device
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Jun 1995
Decision
169d
Days
Class 1
Risk

K946209 is an FDA 510(k) clearance for the DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Med-Plastics Intl., Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 8, 1995 after a review of 169 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.

FDA 510(k) Submission Details - K946209

510(k) Number K946209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date June 08, 1995
Days to Decision 169 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
29d slower than avg
Panel avg: 140d · This submission: 169d
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 50
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K946209.
HUMID-VENT 2
K952844 · Gibeck, Inc. · Jul 1995
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE
K952823 · Icor AB · Jul 1995
HUMID-VENT FILTER PEDI
K952084 · Gibeck, Inc. · Jun 1995
FLEXLIFE
K952036 · Mallinckrodt Medical · Jun 1995
HUMID-VENT MICRO
K951856 · Gibeck, Inc. · Jun 1995
AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H
K945359 · Artema Medical AB · Feb 1995
K946209 · DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
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