Cleared Traditional

K935036 - HEPA FILTERED HEAT AND MOISTURE EXCHANGER

K935036 is an FDA 510(k) clearance for HEPA FILTERED HEAT AND MOISTURE EXCHANGER, manufactured by Intertech Resources, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K935036 · Intertech Resources, Inc. · Anesthesiology device
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Jan 1994
Decision
118d
Days
Class 1
Risk

K935036 is an FDA 510(k) clearance for the HEPA FILTERED HEAT AND MOISTURE EXCHANGER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 118 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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K935036

510(k) Number K935036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 29, 1993
Decision Date January 25, 1994
Days to Decision 118 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
22d faster than avg
Panel avg: 140d · This submission: 118d
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 23
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K935036.
HYGROLIFE
K942794 · Mallinckrodt Medical · Aug 1994
HYGROSTER
K941585 · Mallinckrodt Medical · Apr 1994
TRACHEOLIFE
K941535 · Mallinckrodt Medical · Apr 1994
VAPORTEMP HEAT AND MOISTURE EXCHANGER
K922946 · Mallinckrodt Medical · Mar 1993
5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID
K923865 · Vital Signs, Inc. · Feb 1993
BREATHE EASY
K914336 · Vital Signs, Inc. · Mar 1992