Cleared Traditional

K874597 - THERMOVENT 600

K874597 is an FDA 510(k) clearance for THERMOVENT 600, manufactured by Portex, Inc.. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K874597 · Portex, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1988
Decision
71d
Days
Class 1
Risk

K874597 is an FDA 510(k) clearance for the THERMOVENT 600, 1200, T, 02. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Portex, Inc. (Wilmington, US). The FDA issued a Cleared decision on January 19, 1988 after a review of 71 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 Portex, Inc. devices

FDA 510(k) Submission Details - K874597

510(k) Number K874597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date January 19, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
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 26
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K874597.
BREATHE EASY
K914336 · Vital Signs, Inc. · Mar 1992
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · Intertech Resources, Inc. · Dec 1990
HUMIDI-FLEX TM
K885313 · Life Design Systems, Inc. · Oct 1989
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
K864095 · Gambro, Inc. · Feb 1987
AMERICAN PHARMASEAL HUMIDAIR CONDENSER
K854012 · American Pharmaseal Div. Ahsc · Dec 1985
SERVO HUMIDIFIER 153
K852601 · Siemens Elema AB · Jul 1985