Cleared Traditional

K945657 - DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER

K945657 is an FDA 510(k) clearance for DISPOSABLE HEAT AND MOSITURE EXCHANGER ..., manufactured by Tec II Medical, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K945657 · Tec II Medical, Inc. · Anesthesiology device
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Dec 1994
Decision
20d
Days
Class 1
Risk

K945657 is an FDA 510(k) clearance for the DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Tec II Medical, Inc. (Winfield, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 20 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 Tec II Medical, Inc. devices

FDA 510(k) Submission Details - K945657

510(k) Number K945657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date December 07, 1994
Days to Decision 20 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
120d faster than avg
Panel avg: 140d · This submission: 20d
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 K945657.
DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
K946209 · Med-Plastics Intl., Inc. · Jun 1995
FLEXLIFE
K952036 · Mallinckrodt Medical · Jun 1995
FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT
K950447 · Vital Signs, Inc. · Feb 1995
HEAT AND MOISTURE EXCHANGER FILTER (HME)
K943915 · Medicomp, Inc. · Oct 1994
HYGROLIFE
K942794 · Mallinckrodt Medical · Aug 1994
HEAT AND MOISTURE EXCHANGERS AND FILTERS
K941987 · Icor AB · Aug 1994